BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR SKIN STAPLER

    MDR report key: 5670946 · Received May 23, 2016

    Report

    Report Number
    5670946
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 25, 2016
    Report Date
    May 2, 2016
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE SKIN EDGE WAS APPROXIMATED AND THE STAPLER WAS PLACED ON THE SKIN EDGE IT FIRED BUT DID NOT BRING THE SKIN TOGETHER AS INTENDED. A DIFFERENT STAPLER WAS USED WITH SAME RESULTS. THE PHYSICIAN THEN SUTURED THE C/SECTION INCISION RATHER THAN USING THE STAPLES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328277 INSORB SUBCUTICULAR SKIN STAPLER STAPLER, SURGICAL GDW INCISIVE SURGICAL, INC. 153101

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR