BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3932679 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04930
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION REQUESTED AND OBTAINED: FOLLOW-UP RESPONSE RECEIVED BY THE SALES REP VIA PHONE: WHICH FIRING OF THE DEVICE DID THE EVENT OCCUR? UNKNOWN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNKNOWN. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? 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. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. WHAT IS THE LOT NUMBER OF THE DEVICE? UNKNOWN. IS THE DEVICE AVAILABLE TO BE RETURNED? NO. WHERE SHOULD THE SHIPPER KIT BE SENT? N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE DEVICE WAS FIRED USING THE PULSING METHOD. ON ONE OF THE FIRINGS WITH A GREEN CARTRIDGE USING SEAM GUARD BUTTRESSING ON GASTRIC TISSUE, THE STAPLES DID NOT FORM ON ONE SIDE. THE DEVICE CUT BUT DID NOT STAPLE. THE AREA WAS OVER SEWED. THERE WERE NO USUAL NOISES WITH THE FIRING. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409781 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD ECR60G