BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY LLC

    MDR report key: 3736549 · Received April 4, 2014

    Report

    Report Number
    MW5035537
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ETHICON ENDO-SURGERY LLC, JOHNSON & JOHNSON
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAND ASSISTED LAPAROSCOPIC NEPHRECTOMY ECHELON STAPLER PLACED ON TISSUE. ENGAGES X1 (SHOULD BE 3 SQUEEZES) BUT WOULD NOT ALLOW MD TO ENGAGE AGAIN. COULD SEE THAT BLADE HAD COME OUT SLIGHTLY. MD UNCOMFORTABLE WITH RELEASING SINCE HE SAW THE BLADE. NEW 12 PORT PLACED. POWER ECHELON TESTED PRIOR TO USE, INSERTED AND WORKED. MD THEN ABLE TO PUT IN RESERVES AND RELEASE STAPLER. PT WITH ABOUT 200 CC BLOOD LOSS. ATS45, LOT 14E44X, EXP 2/2018. VASCULAR RELOADS TR45W, LOT J4C947, EXP 8/2017. EC45A ECHELON FLEX 45, LOT K4DM6U, EXP 10/2016. RELOADS FROM ECR45W, LOT K4DV07, EXP 11/2018. BOTH ETHICON STAPLERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205508 ETHICON ENDO-SURGERY LLC ETHICON STAPLER GDW ETHICON ENDO-SURGERY LLC, JOHNSON & JOHNSON ATS45 14E44X
    205509 VASCULAR RELOADS ETHICON STAPLER GDW ETHICON ENDO-SURGERY LLC, JOHNSON & JOHNSON TR45W J4C947
    205510 RELOADS ETHICON STAPLER GDW ETHICON ENDO-SURGERY LLC, JOHNSON & JOHNSON ECR45W K4DV07
    205596 ECHELON FLEX 45 ETHICON STAPLER GDW ETHICON ENDO-SURGERY LLC, JOHNSON & JOHNSON EC45A K4DM6U

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR