BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1083053 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00660
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 23, 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

    D4; H4, 6: INFO 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 THE HOLE CIRCUMFERENCE. IT ONLY STAPLED HALF OF THE LINE. A SECOND STAPLER WAS USED. PATIENT'S CURRENT STATUS IS GOOD. NO SPECIAL ATTENTION REQUIRED.

    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