BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

    MDR report key: 1419694 · Received April 16, 2009

    Report

    Report Number
    3005075853-2009-02354
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Date of Event
    March 26, 2009
    Report Date
    April 8, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE BOTTOM OF THE DEVICE WAS TORN. USED A NEW ONE TO COMPLETE THE CASE. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1