BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB

    MDR report key: 588398 · Received April 4, 2005

    Report

    Report Number
    MW1035084
    Event Type
    Malfunction
    Date Received
    April 4, 2005
    Date of Event
    March 16, 2005
    Report Date
    March 28, 2005
    Manufacturer
    INCISIVE SURGICAL INC
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CESAREAN SECTION, AND IN CLOSING THE INCISION, TWO PHYSICIANS WERE PRESENT USING THE INSORB STAPLER. IT MISFIRED AFTER 3/4 OF INCISION WAS CLOSED. IT WOULD FIRE THE STAPLES BUT THEY WOULD NOT IMPLANT UNDER THE SKIN PROPERLY. THEY HAD TO BE PICKED OUT AND DISCARDED. ANOTHER INSORB STAPLER WAS OPENED AND PERFORMED ACCURATELY. THERE WAS NO INJURY TO THE PT AND THE SKIN CLOSURE WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB STAPLER GDT INCISIVE SURGICAL INC * 044802

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other