BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM CURVED

    MDR report key: 4123450 · Received September 26, 2014

    Report

    Report Number
    3005075853-2014-06701
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE MET RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, INSTRUMENT DID NOT CUT COMPLETELEY, COULD ONLY BE REMOVED OUT OF SITUS WITH APPLICATION OF FORCE, TOOK NEW INSTRUMENT TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602343 ILS 29MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EP97

    Patients

    Seq Age Sex Outcome Treatment
    1