BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR MARYLAND DISS.FCPS 5MM 310MM

    MDR report key: 4618004 · Received March 9, 2015

    Report

    Report Number
    2916714-2015-00197
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Date of Event
    November 28, 2014
    Report Date
    March 9, 2015
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    U.S. REPORTING AGENT NOTIFIED ON: (B)(4) 2015, 510 (K); K001330; K003608. MFG SITE EVAL: COMPLETE INSTRUMENT W/PROTECTOR AND CONNECTING CABLE REC'D FOR INVESTIGATION. JAW OF FORCEPS IS BENT. CERAMIC INSULATION SHOWS CRACKS AND CHIPPED-OFF FRAGMENTS. THE BENT JAW IS AN INDICATION OF EXCESSIVE MECHANICAL FORCE APPLIED TO THE INSTRUMENT. ALL DELICATE BIPOLAR INSTRUMENTS ARE REVIEWED PRIOR TO SHIPPING, THEREFORE, THE DAMAGE TO THE CERAMIC INSULATION CAN ALSO BE ATTRIBUTED TO MECHANICAL OVERLOAD. NO MATERIAL OR PRODUCT DEVIATIONS COULD BE VERIFIED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). BREAK OF THE CERAMIC INSULATION - PIECES FELL INTO THE PT. THE USER IS NOT SURE THAT ALL THE PIECES WERE REMOVED FROM THE PT. CONSEQUENCES: ANY X-RAY PERFORMED - MAYBE A PART REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160848 BIPOLAR MARYLAND DISS.FCPS 5MM 310MM FORCEPS GEI AESCULAP AG & CO KG PM401R

    Patients

    Seq Age Sex Outcome Treatment
    1