Stapler Mishaps in Live Donor Nephrectomy

[Babs (Kidney Donor 4/11/14)]

Hello.  I donated my left kidney to my brother on April 11, 2014 at Piedmont Hospital in Atlanta, GA (Mason Transplant Clinic).  I'm 56 and my brother is 58.  I chose to have the robotic surgery.  Everything went textbook until the final step of separating the kidney from the renal artery and renal vein.  An "unaccounted for" metal clip got in the way of the stapler, allowing it to cut but not staple my artery on my side (the part that was to stay in me and not go with the kidney) and I went into shock due to acute blood loss.  Apparently, I lost two pints of blood in about 5 seconds.  I  had to have two transfusions and ended up in ICU for a couple of days. My surgeon literally saved my life by putting his hand in the lower bikini line incision--used to bag the kidney and remove it--so that he could put pressure on the bleed, and with his other hand, he cut my abdomen open from top to bottom so he could "get in there" and stop the bleeding with sutures.

It's been 5 months and I seem to be "fine."  Just wondering if this has happened to anyone else.

[Fr Pat]

     No, nothing like that happened to me. But I do remember that when I donated 12 years ago the doctor told me that he would use the large open-cut method (one big 10-12 inch incision rather than the laparoscopic method )because he considered it safer for me for him to be able to SEE everything directly (not through a scope and TV screen) so that IF there was excessive bleeding he could see it and get right to it to fix it immediately. So the open method does have that advantage in case anything goes wrong. I'm very glad all worked out well for you.
   best wishes,
   Fr. Pat

[PastorJeff]

I'm glad you're ok too.  The idea of someone running a staple gun inside me was a bit unsettling.  Sounds like something you would do in the garage. 

[elephant]

Dear BabsCox,

I'm so happy to hear you have recovered fully, and hope your brother is doing well too. It must have been shocking to wake up in the ICU and hear your story. 

Love, elephant

[Babs (Kidney Donor 4/11/14)]

Thanks, all.  My brother is doing well, thank goodness. He and his wife are very much enjoying their first grandchild, a little girl who was born at the end of June. They had to do a couple of biopsies on his new kidney--he calls her "Babs" after my maiden initials (BAB)--but there was no cellular rejection.  Just some prograff toxicity, so they have finally, after 5 months, switched him to a different med.

The first thing I remember is hearing a nurse say, "they had to open her up" and something about ICU.  Never been through an experience like that one--tube down my throat in case I got nauseous--very painful to swallow.  But throwing up would have been excruciating with the unexpected 9" incision down my abdomen. I mainly kept myself medicated so I'd stay asleep. Lost about 12 pounds in the hospital--had no appetite, which extended beyond the hospital. That's fine now.

My surgery was at 7:30 AM on a Friday and I was not moved to the transplant floor until 11:30 PM on Saturday night.  I did not get to see my brother until Sunday morning--not exactly how we anticipated things going following surgery.  Needless to say, he felt horrible for what happened to me.  Certainly was not his fault, though.

My surgeon has stopped using the surgical metal clips because of what happened to me.  He says he now closes veins with energy (heat).  Cauterizes them.  Interesting.   

[sherri]

Babs,

Glad to hear that you are ok. Very scary indeed!
There has been some discussion here about Hemolock clips. Not sure if this is the one that was used in your case.

Here is a copy of some of the discussion. You can search on the forum for hemolock and you will see the thread.

Sherri


for Donors-To-Be, & people knowing Donors-To-Be:

   (Heading of the FDA-HRSA joint warning:
  "  FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy
   Date Issued:  May 5, 2011
   Audience: Urologists, Transplant Surgeons, Kidney Transplant Physicians, Hospital Administrators, Hospital Risk Managers, Clinical Transplant Coordinators, Operating Room Supervisors and Staff, and Patients
   ...
   Purpose: ...  Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor.
   Background:
InApril 2006, the manufacturer ... added this contraindication to the Instructions for Use after receiving 15 medical device reports of 12 injuries and three deaths,.. between Nov. 19, 2001 and March 20, 2005 ... associated with [closing] the renal artery during laparoscopic living-donor nephrectomies.
Since ... 2006, there have been three more kidney donor deaths, all associated with the contraindicated use.
   Recommendations:
   ....
   Patients:
    If you are considering donating a kidney, talk to your health care provider about:
        potential for surgical complications;
        methods used during living-donor surgery, and the advantages and disadvantages of each method; and
        risks and benefits associated with donating a kidney.
    If you have donated a kidney and have any questions or concerns about your surgical procedure, contact your doctor."

( http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm253237.htm )
           [all "glow" was added by WLF for emphasis]

WLF's comments:

   1]   Donors-To-Be:  I will be clearer.  Ask your surgeon if she/he uses Hem-o-lok clips -- then tell her/him that you know about this FDA-HRSA Warning and refuse the surgery if it is to be used.  (Even if you feel uncomfortable talking that way to your surgeon-to-be, do it anyway.  It is your life, not the surgeon's.  Tell the transplant center person you deal with the same thing.)

   2]   LDO On-Line:  if it is possible,  please add this to the list of things that Donors-To-Be should do -- perhaps first on the list.  This added step could be life-saving.

   3]   Jennifer & NKF:  if it is possible, please add this to NKF's infor for Donors-To-Be -- perhaps first on your list.  You added step could be life-saving.

   4]   Donor bloggers:  Please put this warning on your blog -- preferably at the top -- for the same reason.

   5]    As a physician & member of my hospital's Quality Assurance Committee,  I know that such notices need to spread by multiple channels of communication, not just one channel.  Only redundancy can increase compliance to 100% -- a lesson the airline industry knows all too well.  Although this warning says it is for patients, I do not see what the FDA & HRSA are doing to send it to Donors-To-Be.  LDO, NKF, & donor-bloggers: I hope you will do that for the FDA & HRSA.

   6]   Although I do not know for sure, this re-sending of this warning may be related to a recent post-operative death of a living kidney donor.   

   7]   The warning is not completely accurate.  Current Living kidney donors are at no risk to have their renal artery suddenly blow open, regardless of the type of closure the surgeon used.  The body forms scar tissue around and within the stump of the renal artery -- well before 2 weeks post-op.  That scar is the permanent closure.  Current LKDs do not need to ask their Transplant Center or surgeon anything about their own surgery.  (Feel free, however, to ask your Center & surgeon if anyone uses Hem-o-loks for donor nephrectomies -- to let the Center & surgeon know that LKDs are concerned about the continued use by a few even though contraindicated!)

Bill
« Last Edit: May 10, 2011, 12:45:08 PM by WilliamLFreeman »

[Waiting2donate]

My surgeon has done a several hundred nephrectomies over a decade and said that I was the first patient to ever ask about the Hem-o-lok clip. Does not sound like Babs' issue. Hard to imagine how that happened since they can see what they're doing on large magnified monitors. If it were common, they would change the procedures. Glad to hear all ended well, scary to wake up with a different outcome than you expected.

[Babs (Kidney Donor 4/11/14)]

Waiting2donate is correct--the issue was not a Hem-o-lok clip.  Metal clips (the standard now) were used during my surgery. The issue was an unaccounted for metal clip (guess the surgeon didn't see it) which did not allow the tool that cuts and clips the renal artery and vein to staple the artery.  It only cut it.....allowing me to almost bleed out.  What happened to me was rare...a fluke.  I know WHAT happened....I just don't know WHY.  Maybe my surgeon was in too big of a hurry.  He called me from the Cayman Islands the following week to check on me.  However, I would totally donate again....it has not made me regret my decision to help my brother for a second.

[Babs (Kidney Donor 4/11/14)]

I did a little research and found an article in The Journal of Urology from 2001 which mentions the electrocautery method my surgeon said that he now uses instead of clips--because of what happened to me.  "Purpose:  We describe a technique enabling easier placement of the endoscopic linear stapling device on the renal vein during laparoscopic nephrectomy."  "Conclusions:  Bipolar electrocautery of the renal vein branches enables EASIER placement of the endoscopic linear stapling device on the renal vein and the use of fewer surgical clip appliers during laparoscopic surgery." (emphasis added).  I have attached a picture of my post-surgery staples.  As you can see, the incision up the middle of my abdomen should not have been there.  I cannot help but believe that mine was just a case of human error on my surgeon's part.

[Snoopy]

Hard to imagine how that happened since they can see what they're doing on large magnified monitors. If it were common, they would change the procedures.

A few year ago, a kidney donor died during the surgery when her aorta was cut.  A former (liver) transplant surgeon at the same center told me later that that's the sort of death that would not have happened 20 years earlier, because they would have had better, faster access to catch it, and get on top of things with the older, "open" procedure.  There are lots of advantages to the newer, "closed" technique, but trade-offs of various types are common all throughout medicine and technology.  Such disasters are thankfully rare, but they can happen.
    Be well, Snoopy