BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 2142447 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02637
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    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). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. SPRING CARTRIDGE LOCKOUT TAB THE ANALYSIS SHOWED THAT THE ATW35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE RELOAD LOCK OUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. ADDITIONALLY THE CARTRIDGE RETENTION FEATURES WERE DAMAGE CONSISTENT WITH THE DAMAGED OBSERVED WHEN A LOCKED RELOAD IS ATTEMPTED TO FIRE WITH ENOUGH FORCE TO EJECT THE RELOAD FORWARD. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS LOADED IN THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FELL OUT DURING THE VISUAL AND FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC RADICAL NEPHRECTOMY. ON THE 1ST FIRING ACROSS THE RENAL ARTERY, THE DEVICE WAS CLOSED, WAITED 15 SECONDS AND ATTEMPTED TO FIRE. THE FORCE TO FIRE WAS HIGH AT FIRING AND WHEN IT WAS FIRED IT "POPPED" AND THE RELOAD CARTRIDGE DROPPED OUT OF THE JAWS AND INTO THE PATIENT'S ABDOMEN. THE RELOAD CARTRIDGE WAS RETRIEVED. THE RENAL ARTERY WAS TRANSECTED DURING THIS FIRING. THE BLEEDING WAS STOPPED WITH A LAP SPONGE. THE PATIENT DID NOT REQUIRE BLOOD TRANSFUSION OR BLOOD PRODUCTS. THE ARTERY WAS CUT AND TIED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH ONE FIRING. ADDITIONAL FOLLOWUP: ON WHAT TISSUE TYPE WAS THE DEVICE USED? RENAL ARTERY. AT WHAT LOCATION ON THE TISSUE? ACROSS THE VEIN. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NONE. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? "POPPING." IF SO, WHEN? WHEN FIRING TRIGGER WAS PULLED TO FIRE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? FIRING . 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4369N

    Patients

    Seq Age Sex Outcome Treatment
    1