BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH 10MM BABCOCK W/HANDLE

    MDR report key: 762907 · Received August 25, 2005

    Report

    Report Number
    1527736-2005-03773
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Report Date
    August 24, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/25/2005. OPEN HANDLE SEAM. EVALUATION: THE ANALYSIS RESULT FOUND THAT THE INSTRUMENT WAS RETURNED WITH THE TWO HANDLE HALVES SEPARATED AT THE RATCHET AND THUMB-RING AREA. THE RATCHET AND THE GRASPING FEATURE OF THE DEVICE WERE FOUND TO BE NON-FUNCTIONAL DUE TO THE HANDLE'S CONDITION. THE HANDLES WERE NOTED TO BE SEPARATED DUE TO A CLEARANCE CONDITION BETWEEN A LOCKING-PIN ON ONE HANDLE HALF TO THE CORRESPONDING HOLE ON THE OTHER HALF THAT REQUIRES INTERFERENCE FIT.

    Description of Event or Problem · 1

    DURING A LAP COLON PROCEDURE, DEVICE COULD NOT BE CLOSED CORRECTLY. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH 10MM BABCOCK W/HANDLE ENDOPATH HAND HELD DEVICE 3MM-5MM-10MM GEI ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN