MAUDE Adverse Event Report: ETHICON ENDO CS40B CURVED STAPLER

Model Number CS40B

Device Problems Nonstandard Device (1420); Contamination of Device Ingredient or Reagent (2901)

Patient Problems Death (1802); Fistula (1862); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 03/04/2010

Event Type  Death  

Event Description

This report is about my mother, (b)(6).She had her first rectal prolapse surgery in (b)(6) 2010.This surgery was unsuccessful.We believe that contaminated recalled sutures may have been used, and possibly a mesh of some kind, also possibly a circular stapler malfunction.Several surgeons stated that they saw and felt mesh, or staples.She had major pain that she described as a broken bottle inside her, slivers of glass all inside her vagina and rectum.She had another rectal prolapse surgery to try and repair again and this time a circular starr stapler was used, her pain worsened.She later had multiple visits to surgeons, obgyn's, family doctor.She was told she had a recto vaginal fistula and had to have a colostomy.Still no pain relief! later she had exploratory surgery done by two surgeons, one went in rectally and the other vaginally under anesthesis.They found a vaginal tumor.Treatments had to be done.These were successful as the tumor couldn't be seen or felt, but nothing else was said about what they believed to be mesh or staples.These statements are documented and also the location of them, which are no where near the location of the tumor.I also do not believe that any of these fine doctors would mistake a tumor for mesh or staples.One of the surgeons passed away shortly after the exploratory surgery, so we were never able to discuss it with him again.She was simply in too much pain and after trying numerous medications, hyperbaric oxygen, etc., to go to anymore doctors and was placed with hospice care.She was on fentanyl patches, methadone, morphine just to name a few of her medications and still complained with the broken bottle, slivers of glass pain inside her rectum and vagina.Sadly, she passed away on (b)(6) 2015.I have since requested all of her medical records and believe that this needs to be pursued.I do not wish for anyone else to go through the horrible, sad, nightmare that my sweet mother had to go through.She suffered for many years and it breaks my heart that think that more people may have this happen to them.(b)(6) medical center, (b)(6) 2010.(b)(64).Pt number (b)(4) suture (b)(4) vicryl- recall was in 2008, issued in 2009.(b)(6) 2010 surgery date stapler(b)(4) curved.(b)(6) 2010 surgery date prolene suture.

• Brand Name: CS40B CURVED STAPLER
• Type of Device: CS40B CURVED STAPLER
• Manufacturer (Section D): ETHICON ENDO
• MDR Report Key: 5263457
• MDR Text Key: 32666311
• Report Number: MW5058235
• Device Sequence Number: 1
• Product Code: GDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/19/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: CS40B
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Disability
• Patient Age: 72 YR