BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2993257 · Received March 7, 2013

    Report

    Report Number
    3005075853-2013-01118
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? FOR HEMORRHOID TREATMENT. AFTER FIRING, WAS THE ADJUSTING KNOB TURNED ½ TO ¾ REVOLUTIONS? YES. WAS THE DEVICE ROTATED 90 DEGREES IN BOTH DIRECTIONS PRIOR TO REMOVING? YES. THE SURGEON TRIED TO DO IT , BUT THE STAPLER WAS STUCK AT ONE POINT AND HENCE HE COULD NOT DO IT COMPLETELY. AFTER REMOVAL, WAS THE STAPLE LINE EXAMINED FOR COMPLETENESS AND OR TEARS? YES, THERE WAS A TEAR AT ONE PLACE AND IT WAS BLEEDING FROM THERE. AFTER REMOVAL, WAS THE STAPLE LINE EXAMINED FOR BLEEDING? YES, THE STAPLE LINE WAS BLEEDING FROM ONE PLACE. WERE THERE TWO COMPLETE TISSUE DONUTS? THERE WAS ONLY ONE DONUT AND IT WAS NOT COMPLETE. ( IN HEMORRHOIDPEXY WE GET ONLY ONE DONUT). WERE ALL TISSUE LAYERS PRESENT IN BOTH DONUTS WHEN INSPECTED? YES, ALL LAYERS WERE PRESENT IN THE DONUT WHEN INSPECTED. HOW WAS THE CASE COMPLETED? THE SURGEON HAS TO STITCH THE BLEEDER . THE HEMORRHOIDAL MASS WAS NOT COMPLETELY EXCISED. WHAT IS THE CURRENT STATUS OF THE PATIENT? THE PATIENT IS GOOD BUT THE HEMORRHOIDAL MASS HAS NOT BEEN COMPLETELY TAKEN CARE OF AND THE SURGEON WILL HAVE TO REDO THE SURGERY.

    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. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE; 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. 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 AN UNKNOWN PROCEDURE THE STAPLER GOT ENTANGLED WITH THE TISSUE AT ONE POINT AND THE SURGEON HAS TO APPLY FORCE TO REMOVE THE STAPLER FROM THE "SITU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97996 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CH5R

    Patients

    Seq Age Sex Outcome Treatment
    1