BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP DISC HAND ACCESS DEVICE

    MDR report key: 1356753 · Received November 8, 2004

    Report

    Report Number
    1527736-2004-03965
    Event Type
    Malfunction
    Date Received
    November 8, 2004
    Date of Event
    October 18, 2004
    Report Date
    October 18, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TORN SLEEVE/IRIS. EVALUATION SUMMARY: INSTRUMENT A WAS RETURNED WITH THE PACKAGING TRAY AND DRIED BODY FLUIDS. DEVICE WAS RETURNED WITH THE IRIS TORN AND ATTACHED TO THE UPPER RING. THE SLEEVE WAS FOUND TO BE TORN AND ATTACHED TO THE FLEX RING. FUNCTIONAL TESTING COULD NOT BE CONDUCTED DUE TO CONDITION OF RETURNED INSTRUMENT. THE UPPER AND LOWER RING TEETH ARE INTACT AND UNDAMAGED. THE LOWER PROTECTIVE RING WAS FOUND TO HAVE CUT MARKS ON THE OUTSIDE EDGE OF RING THAT ARE CONSISTENT WITH THE TEAR ORIGINATION POINT OF THE IRIS AND SLEEVE. BASED UPON THE INQUIRY INFORMATION RECEIVED AND VISUAL EXAMINATION IT WAS CONCLUDED THAT THE LAP DISC IRIS AND SLEEVE WERE TORN MAKING THE INSTRUMENT NON FUNCTIONAL. ADDITIONAL LOT#: 040225.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND-ASSISTED LAPAROSCOPIC NEPHRECTOMY, TWO LAP DISCS BROKEN UPON INSERTION. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP DISC HAND ACCESS DEVICE HANDOSCOPY LAP DISC GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA 040724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN