BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE CURVED STAPLER

    MDR report key: 3853179 · Received June 6, 2014

    Report

    Report Number
    3005075853-2014-03822
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. ONLY ANVIL HALF 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, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS PLACED IN THE RECTUM AND FIRED. EVERYTHING WORKED PROPERLY. ONCE THE SURGEON ATTEMPTED TO REMOVE THE DEVICE IT GOT STUCK ON TISSUE. THEY TRIED TURNING THE DEVICE A COMPLETE 180 DEGREE. THEY DID EVENTUALLY GET IT TO RELEASE FROM THE TISSUE. HOWEVER, WHEN THE SURGEON WENT BACK TO THE TOP, THE ANASTOMOSIS FELL APART. THEY WERE ABLE TO DO ANOTHER ANASTOMOSIS AND COMPLETED THE CASE. THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332698 PROXIMATE CURVED STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E91C

    Patients

    Seq Age Sex Outcome Treatment
    1