BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 33MM, STRAIGHT

    MDR report key: 3193185 · Received June 27, 2013

    Report

    Report Number
    3005075853-2013-03321
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; 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 COMPLAINT COULD NOT BE CONFIRMED. 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 ¿CELECTOY¿ WHEN FIRING THE INSTRUMENT THERE WAS NO CUTTING, ALL STAPLES FORMED PROPERLY. THE INSTRUMENT GOT STUCK ON THE TISSUE AND THEY HAD TO CUT IT LOOSE. A NEW INSTRUMENT WAS USED TO CONTINUE THE SURGERY. PATIENT WAS STABLE THE SURGEON FIRED THE DEVICE AND REPORTED TO BE AN EXPERIENCED USER. THE SURGEON COMMENTED, ¿I THINK THIS WAS MY OWN MISTAKE, SO I DON¿T SEE ANY NEED TO GO FORWARD WITH THIS.¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294417 ILS 33MM, STRAIGHT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CM6F

    Patients

    Seq Age Sex Outcome Treatment
    1