BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1172473 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01847
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 16, 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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 9/22/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY PROCEDURE, FROM THE 3 O'CLOCK TO 6 O'CLOCK POSITION OF THE STAPLE LINE, THE STAPLES WERE NOT FORMED PROPERLY AND DID NOT CLOSE TO A B SHAPED FORMATION. THERE WAS BLEEDING AND THE SURGEON HAD TO STITCH OVER THE STAPLE LINE TO ENSURE COMPLETE HEMOSTASIS. PATIENT WAS ALRIGHT AND DID NOT DEVELOP ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET GDW ETHICON ENDO-SURGERY, LLC NA E4LF9P

    Patients

    Seq Age Sex Outcome Treatment
    1