BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1082917 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00693
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMOROIDOPEXY PROCEDURE, AFTER DOING ALL THE STEPS NECESSARY IN THE PROCEDURE. AFTER CLOSING THE MACHINE, WAITED 1M AND THEN FIRED THE STAPLER, PLASTIC TO PLASTIC, THE DEVICE DID NOT ACT AS ALWAYS. IT DID NOT STAPLE CORRECTLY. SURGERY WAS PROLONGED 15 MINUTES. A SECOND STAPLER WAS USED (NOT A MEDICAL INTERVENTION). PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET GDW ETHICON ENDO-SURGERY, LLC. NA E4KM9Z

    Patients

    Seq Age Sex Outcome Treatment
    1