BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1915710 · Received February 4, 2008

    Report

    Report Number
    1527736-2008-00679
    Event Type
    Malfunction
    Date Received
    February 4, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE, THE STAPLER CUT PARTIALLY BUT DID NOT STAPLE AT ALL. ANOTHER LIKE DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HC8N

    Patients

    Seq Age Sex Outcome Treatment
    1