BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP DISC HAND ACCESS DEVICE

    MDR report key: 745797 · Received July 1, 2005

    Report

    Report Number
    1527736-2005-02975
    Event Type
    Malfunction
    Date Received
    July 1, 2005
    Date of Event
    June 16, 2005
    Report Date
    June 19, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # 040908.

    Description of Event or Problem · 1

    DURING AN UNK PROCEDURE, THE DEVICE RIPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THECASE THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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. NA 050226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN