BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED INTRALUMINAL STAPLER

    MDR report key: 8599566 · Received May 9, 2019

    Report

    Report Number
    MW5086514
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    January 30, 2019
    Report Date
    May 7, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, INC. / JOHNSON AND JOHNSON
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COLECTOMY SURGERY INVOLVED AN ETHICON ENDO-SURGERY CURVED INTRALUMINAL STAPLER (PRODUCT CODE CDH33A) WHICH FAILED AFTER SURGERY CAUSING BLOOD AND BOWEL CONTENTS TO SPILL INTO MY ABDOMEN, WHICH RESULTED IN BLOOD LOSS, HEMATOMA, SEVERE LIFE-THREATENING INFECTION, EXTREME PAIN AND REQUIRED EMERGENCY SURGERY ON (B)(6) 2019 TO REPAIR MY BOWEL. ILEOSTOMY WAS ALSO PERFORMED, AS WELL AS AN APPENDECTOMY. I DO NOT KNOW IF AN ETHICON ENDO-SURGERY CURVED INTRALUMINAL STAPLER WAS USED DURING THE REPAIR SURGERY. HOWEVER, I HAVE BEEN MADE AWARE THAT ETHICON ENDO-SURGERY, LLC HAS IMPLEMENTED A RECALL (REMOVAL) OF AT LEAST FOUR (4) DIFFERENT CURVED INTRALUMINAL STAPLERS, AND AT LEAST FOUR (4) DIFFERENT ENDOSCOPIC CURVED INTRALUMINAL STAPLERS. I AM TERRIFIED BY THE PROSPECT OF ADVERSE COMPLICATIONS ASSOCIATED WITH THE MEDICAL DEVICE FROM BOTH SURGERIES. I HAVE LOST OVER 50 LBS, WHILE MAINTAINING A HEALTHY DIET. I AM WEAK ALL THE TIME AND AFRAID OF FALLING OR INJURY. I HAVE LOST WORK AS WELL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387508 CURVED INTRALUMINAL STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, INC. / JOHNSON AND JOHNSON CDH33A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R BENADRYL 25MG AT 2 PRN| GUAIFENESIN 400MG 3-4 TIMES / DAY| METAMUCIL 1 CAP / DAY| MULTIVITAMIN 500MG 1/DAY| ONE ALPRAZOLAM 0M5MG/DAY| ONE FLUOXETINE 20MG/DAY| ONE HYDROCODONE W / ACETAMINOPHEN (5-325) EVERY 6 HRS AS NEEDED FOR PAIN| ONE OMEPRAZOLE 20MGDAY| VITAMIN C