BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 3013479 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01328
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 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
    HK
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STAPLED HEMORRHOIDECTOMY AFTER THE PURSE STRING WAS CREATED, THE DEVICE WAS INSERTED TO THE PATIENT. THE STAPLER WAS CLOSED, WAITED FOR 30 SECONDS, THE SURGEON STARTED TO FIRE THE STAPLER. AT THIS MOMENT, SURGEON FOUND THAT THE STAPLER WAS VERY HARD TO FIRE AND MORE FORCE THAN USUAL WAS NEEDED. THE SURGEON COULD FIRE THE STAPLER FINALLY, AND DEFAULT SAMPLE WAS COLLECTED FOR FURTHER INVESTIGATION. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. NO PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    SUTURE WAS USED TO CONTROL THE BLEEDING. A SECOND DEVICE WAS NOT USED. A CRUNCH SOUND WAS HEARD INDICATING THE DEVICE WAS FULLY FIRED. THERE WAS A HIGH FORCE FIRE. THE TISSUE COMPRESSION/GAP SETTING SCALE WAS SET AT 0.75 MM. THE STAPLES OBSERVED IN THE TISSUE. ALL TISSUE LAYERS WERE PRESENT BUT THEY WERE SMALLER THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116214 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1