FDA Adverse Event Death Summary report: N

COVIDIEN STAPLER

MDR report key: 8174241 · Received December 17, 2018

Report

Report Number
MW5082183
Event Type
Death
Date Received
December 17, 2018
Date of Event
October 10, 2017
Report Date
December 14, 2018
Manufacturer
COVIDIEN
Product Code
GAG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IS
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

DEAR REP, MY NAME IS (B)(6), I'M (B)(6) LIVE IN (B)(6). MY MOTHER, REST IN PEACE, PASSED AWAY 3 MONTHS AGO. AFTER A SUCCESSFUL WHIPPLE SURGERY, THAT WAS HELD IN (B)(6) MEDICAL CENTER, (B)(6). DURING OUR INVESTIGATION, WE GOT ALL DOCUMENTS REGARDING THE SURGERY, MEDICAL NOTES, LIST OF ALL INSTRUMENTS, APPLIANCE AND DEVICE WERE USED IN HER SURGERY. WE GOT A DECLARATION MADE BY (B)(6) MEDICAL CENTER, DECLARING THAT A MAJOR UNEXPECTED AND RARE FAILURE OF COVIDIEN STAPLER WAS THE CAUSE. OF THE COMPLICATION, WEEKS OF HOSPITALIZATION, 4 OPERATIONS TRYING TO FIX WHAT WAS ALREADY UNFIXABLE, AND FINALLY SHE DIED FROM SEPSIS. WE ALSO GOT THE SURGEON DECLARATION, SAYING CLEARLY, THAT COVIDIEN STAPLER WAS DEFECTIVE. WE HAVE TODAY OFFICIAL DOCUMENTS REGARDING COVIDIEN AND MEDTRONIC WAY OF HANDLING THIS. KNOWN TECHNICAL PROBLEMS, FDA INVOLVEMENT, RECALLS, 2012 / 2013 FINANCIAL STATEMENTS, WARNING YOUR PUBLIC INVESTOR, LAWSUITS, LITIGATION, AND COMPENSATION SETTLEMENT, STATISTICS REGARDING ALL NUMBERS IN CONNECTION WITH STAPLERS MALFUNCTION. MY MOTHER WAS (B)(6), SHE DIED WITHOUT SAYING GOODBYE TO HER HUSBAND, CHILDREN AND GRANDCHILDREN. WE ALL WILL NEVER EVER SEE HER AGAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1012068 COVIDIEN STAPLER STAPLER, SURGICAL GAG COVIDIEN I DON'T HAVE IT

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death| H| L| O| S