BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2840453 · Received November 20, 2012

    Report

    Report Number
    3005075853-2012-05291
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? N/A. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BEFORE- 2 GREEN. AFTER- 2 BLUE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, ON THE FIFTH FIRING THE DEVICE (WHITE RELOAD) STOPPED FIRING ABOUT 10MM THROUGH THE CARTRIDGE. THEY WERE STAPLING THROUGH A VESSEL. THE REVERSE BUTTON WAS USED TO RETURN THE KNIFE TO PROXIMAL END OF JAW AND OPEN THE STAPLER. THE NURSE TOOK THE ECHELON GUN FOR HOSPITAL REVIEW AND WE OPENED A NEW DEVICE TO FINISH THE CASE. THE DOCTOR SUTURED THE VESSEL WHERE THE DEVICE JAMMED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CE53

    Patients

    Seq Age Sex Outcome Treatment
    1