BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP DISC HAND ACCESS DEVICE

    MDR report key: 1831678 · Received September 12, 2007

    Report

    Report Number
    1527736-2007-06008
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 22, 2007
    Report Date
    August 29, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SPLENECTOMY PROCEDURE THE TOP RING BROKE FROM THE BOTTOM RING OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP DISC HAND ACCESS DEVICE GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) NA 060715

    Patients

    Seq Age Sex Outcome Treatment
    1