BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 25MM CURVED

    MDR report key: 3870045 · Received June 12, 2014

    Report

    Report Number
    3005075853-2014-03946
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 20, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE CDH25A 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. ONLY CASING HALF WASHER WAS 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. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HALS LOW ANTERIOR RESECTION PROCEDURE, THE FIRST ASSIST ATTEMPTED TO FIRE THE DEVICE AFTER HOLDING FOR THE RECOMMENDED THIRTY SECONDS AND WAS NOT ABLE TO GET THE TACTILE AND AUDIBLE FEEDBACK FROM THE WASHER BREAKING. SHE STATED THAT THE HANDLE WAS PLASTIC TO PLASTIC AND SHE COULD NOT SQUEEZE THE FIRING TRIGGER ANY FURTHER. SHE THEN LET OFF THE HANDLE OPENED THE DEVICE BY TURNING THE DIAL IN THE "OPEN" DIRECTION. SHE THEN CLOSED THE DEVICE AGAIN AND TRIED TO FIRE FOR A SECOND TIME, AGAIN NOT GETTING THE FEEDBACK SHE WAS EXPECTING. WHEN THEY OBSERVED THE ANASTOMOSIS AFTER REMOVING THE STAPLER THEY NOTICED THAT SOME OF THE STAPLES WERE FORMED ("B"), AND SOME WERE NOT FORMED AT ALL (IN THE SHAPE OF A "U"). THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347762 ILS 25MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E89W

    Patients

    Seq Age Sex Outcome Treatment
    1