BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 3033718 · Received April 3, 2013

    Report

    Report Number
    3005075853-2013-01576
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 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 Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT SHOULD BE NOTED THAT TO REMOVE THE DEVICE AFTER A COMPLETE FIRING STROKE, OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORROIDOPEXY PROCEDURE THE SURGEON STATED THAT THE DEVICE WAS DIFFICULT TO REMOVE AFTER THE DEVICE HAD COMPLETED ITS FIRING SEQUENCE. THE STAPLE LINE WAS INTACT, BUT HE SUTURED FOR EXTRA STABILITY. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136525 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CA1C

    Patients

    Seq Age Sex Outcome Treatment
    1