BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULAR STAPLER 29MM DIGITAL LOADING UNIT

    MDR report key: 1062339 · Received June 18, 2008

    Report

    Report Number
    2532140-2008-00028
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K032701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CS29 AND IDRIVEC WERE BOTH RETURNED FOR ANALYSIS AND THE CS29 POCKETS SHOWED NORMAL STAPLE FORMATION. THE IDRIVEC PERFORMED AS INTENDED WHEN A CS29 WAS INSTALLED. THE FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    DURING A LEFT COLECTOMY PROCEDURE, WHILE FIRING A CS29 VIA AN IDRIVEC, THE CS29 CUT TISSUE, BUT DID NOT DEPLOY STAPLES. THE PROCEDURE WAS COMPLETED BY USE OF SUTURES AND ANOTHER CS29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCULAR STAPLER 29MM DIGITAL LOADING UNIT STAPLE, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS PM-000219

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INTELLIGENT DELIVERY SYSTEM CURVED (IDRIVEC)