BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1831404 · Received December 20, 2007

    Report

    Report Number
    1527736-2007-08696
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Report Date
    December 12, 2007
    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
    GM
    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 HEMORRHOIDOPEXY PROCEDURE, THE DEVICE DID NOT STAPLE COMPLETELY, NO FURTHER INFORMATION IS AVAILABLE. SUTURED BY HAND. 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 D4H89E

    Patients

    Seq Age Sex Outcome Treatment
    1