BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1083271 · Received July 29, 2008

    Report

    Report Number
    3005075853-2008-00754
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STAPLED HEMORRHOIDECTOMY PROCEDURE, MOST OF THE STAPLES WERE NOT WELL FORMED AFTER FIRING. SEVERE BLEEDING FROM A STAPLE LINE REQUIRED THE DOCTOR TO APPLY MANY STITCHES TO STOP BLEEDING AND CLOSE A STAPLE LINE. THE PLASTIC WASHER (INNER AND OUTER RING) FELL APART FROM THE ANVIL, AND THE RING APPEARED UNEVENLY CUT BY THE BLADE. HOSPITALIZATION, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention