BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP DISC HAND ACCESS DEVICE

    MDR report key: 810777 · Received January 16, 2007

    Report

    Report Number
    1527736-2007-00294
    Event Type
    Malfunction
    Date Received
    January 16, 2007
    Date of Event
    November 1, 2006
    Report Date
    January 9, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    k010870
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4: SERIAL #=NA; LOT NUMBER = 051008 (SECOND NUMBER PROVIDED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICES RIPPED DURING THE CASE. UNK HOW CASE WAS COMPLETED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP DISC HAND ACCESS DEVICE GCJ GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA 060216

    Patients

    Seq Age Sex Outcome Treatment
    1 YR