BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1872594 · Received September 27, 2010

    Report

    Report Number
    1872594
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 27, 2010
    Manufacturer
    RICHARD WOLF
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE: A SMALL HOLE WAS MADE IN THE TRANSVERSE MESOCOLON JUST TO THE LEFT OF LIGAMENT OF TREITZ. THE SMALL BOWEL WAS THEN DELIVERED THROUGH THIS AND UP INTO THE LESSER SAC. AT THIS POINT, THE PROXIMAL GASTRIC POUCH WAS GRASPED AND ELEVATED. A SMALL GASTROTOMY WAS MADE IN THE LATERAL PORTION OF THE STOMACH. A STAPLER WAS CHOSEN AND UTILIZED AT THIS TIME. THE ANVIL AND TROCAR WERE PLACED INTO THE ABDOMEN. THIS WAS PLACED THROUGH THE OPENING IN THE STOMACH POUCH AND EXITED FROM THE MID PORTION OF THE POUCH. THIS WAS THEN CLOSED USING A STAPLER. WHILE TRYING TO REMOVE THE TROCAR OR THE ANVIL, THE GRASPER INSTRUMENT HAD ONE OF ITS SIDES FRACTURE. THIS PIECE WAS REMOVED INTACT. THERE WAS NO INJURY TO THE PATIENT. THERE DID NOT APPEAR TO BE ANY RETAINED PIECES. THE REMOVED PIECE DID FIT NICELY IN WITH THE INSTRUMENT WHERE IT BROKE OFF FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LAPRASCOPIC INSTRUMENT; DOUBLE ACTION SMOOTH GRASPER GCJ RICHARD WOLF 8383-2937 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR