BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

    MDR report key: 3883054 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00094
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Report Date
    February 17, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K001330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    G5: K001330: K003608. MANUFACTURING SITE EVALUATION: THE GREY CERAMIC INSULATION SHOWS A CRACK AND A SMALL PIECE IS BROKEN OFF. THIS FAILURE OCCURRED DUE TO MECHANICAL OVERLOAD, WITH BENDING. THIS IS THE RESULT OF INCORRECT HANDLING. THE INSULTED OUTER TUBE (PM973R) ALSO DISPLAYS SOME CRACKING, WHICH IS THE DIRECT RESULT OF THE DAMAGED JAW INSERT (PM438R). HANDLE (PM450R) AND THE PROTECTIVE CAP (PM433220) DO NOT DISPLAY ANY DAMAGE AND ARE ACCORDING TO SPECIFICATION. THESE INSTRUMENTS ARE CHECKED MICROSCOPICALLY PRIOR TO BEING PLACED IN STOCK. THERE WERE NO MATERIAL OR PRODUCT DEVIATIONS FOUND.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CERAMIC OF DEVICE BROKE, DEVICE USED IN 4 OPERATIONS, UNKNOWN WHEN BREAKAGE OCCURRED. THIS DEVICE IS SOLD IN THE US AS COMPLETE DEVICE, PM408R; EVALUATION IS DONE AT COMPONENT LEVEL, AS FOLLOWS: PM438R-JAW INS.BIP.MARYLAND DISS.FEN.5/310MM, PM973R-INSULATED OUTER TUBE 5/5MM 310MM, PM450R-HANDLE FOR BIPOLAR INSTRUMENTS, PM433220-PROTECTION CAP FOR BIPOLAR JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103904 MARYLAND GSP.FORCEPS FEN.5/310MM HF CON. GEI / HGI GEI AESCULAP AG & CO. KG PM408R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other