BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 3200252 · Received July 1, 2013

    Report

    Report Number
    3005075853-2013-03380
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: BREAKAWAY. WASHER INDENTED THE ANALYSIS RESULTS FOUND THAT ONE WAS RECEIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT, UNCUT AND INDENTED; THE DEVICE WAS RECEIVED WITH ONLY NINE STAPLES PRESENT AND PARTIALLY FORMED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. THIS MAY HAVE CAUSED THE STAPLE TO NOT PROPERLY FORM. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOIDOPEXY PROCEDURE, 90% OF THE STAPLES WERE MISFORMED, BUT CUT COMPLETELY, SUTURED BY HAND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300428 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C71C

    Patients

    Seq Age Sex Outcome Treatment
    1