BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 1850487 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05640
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 8, 2010
    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
    NL
    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. THE DEVICE OPENED AND CLOSED AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY, AFTER PULLING IN THE MUCOSAL LAYER, THE SURGEON EXPERIENCED THAT CLOSING THE DEVICE SEEMED DIFFICULT. HE MANAGED TO CLOSE THE DEVICE WITH THE INDICATOR HALF WAY THE GREEN RANGE SCALE AND FIRED THE STAPLER. AFTER REMOVING THE DEVICE, HE FOUND ONLY A SMALL/MINIMAL BORDER OF MUCOSA WHICH WAS BEING REMOVED. THE ANASTOMOSES WAS INCOMPLETE, ONLY AT THE VENTRAL SIDE CORRECTLY STAPLED STAPLES WERE FOUND. THE REST OF THE STAPLES WERE NOT FORMED AT ALL. TO RESOLVE THE PROBLEM, THE SURGEON PREFORMED A CORRECTION OF THE ANASTOMOSES THROUGH THE RECTUM MANUALLY. THE SURGEON SUSPECTED THAT INITIALLY HE HAD PROPER (ENOUGH) TISSUE TO PERFORM THE PROCEDURE CORRECTLY, BUT THAT SEEMED NOT TO BE THE CASE. THE SURGEON DOESN'T HAVE AN EXPLANATION FOR THIS EVENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4T76W

    Patients

    Seq Age Sex Outcome Treatment
    1