BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE LAPCLINCH GRASPER FORCEPS TIP

    MDR report key: 2976607 · Received February 20, 2013

    Report

    Report Number
    1223422-2013-00007
    Event Type
    Other
    Date Received
    February 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K981389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REF 3252 TIP WILL NOT BE RETURNED BY THE HOSPITAL, THEREFORE NO INVESTIGATION CAN BE CONDUCTED. THE TIP JAWS ARE DESTRUCTIVE TESTED FOR EACH LOT RECEIVED. ALSO, IN BETWEEN EACH WORK STEP, REGULAR INSPECTIONS ARE PERFORMED. BECAUSE THE NUMBER OF TIMES USED IN SURGERY WAS NOT PROVIDED FOR THE TIP LISTED ABOVE AND THE TIP NOT BEING RETURNED A CAUSE FOR THE BROKEN JAW COULD NOT BE DETERMINED. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER. THERE IS NO REMAINING PRODUCT WITH THIS LOT NUMBER IN HOUSE TO EXAMINE.

    Description of Event or Problem · 1

    THE TIP SHEARED ALONG ONE OF THE JAWS TOWARDS THE HINGE. NO HARM TO THE PATIENT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74236 DISPOSABLE LAPCLINCH GRASPER FORCEPS TIP LAPCLINCH TIP GEI MICROLINE SURGICAL INC. 3252 00107465

    Patients

    Seq Age Sex Outcome Treatment
    1