BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP DISC HAND ACCESS DRIVE

    MDR report key: 1065141 · Received June 24, 2008

    Report

    Report Number
    1527736-2008-03771
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCIANNTI)
    Product Code
    GCJ
    PMA / PMN Number
    K010870
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/24/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE DEVICE BROKE DURING THE SURGERY WITHOUT ANY SPECIFIC EXTERNAL INFLUENCE. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1