BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDH 29 ETHICON ENDO STAPLER

    MDR report key: 1593129 · Received January 28, 2010

    Report

    Report Number
    MW5014595
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    January 21, 2010
    Report Date
    January 28, 2010
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A COLOSTOMY CLOSURE, THE PROXIMATE ILS CURVED INTRALUMINAL STAPLER MALFUNCTIONED. THE ANVIL WOULD NOT ATTACH TO THE PROXIMATE STAPLER ONCE IT WAS SECURED IN THE PROXIMAL PORTION OF THE COLON. ANVIL WAS REMOVED AND A NEW STAPLER OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDH 29 ETHICON ENDO STAPLER PROXIMATE INTRALUMINAL STAPLER GAG ETHICON ENDO SURGERY F4P25N
    2 CDH 29 ETHICON ENDO STAPLER PROXIMATE INTRALUMINAL STAPLER GAG ETHICON ENDO SURGERY CDH29

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR