BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAW INS. BIP.MARYLAND DISS.FEN.5/310MM

    MDR report key: 4436212 · Received January 13, 2015

    Report

    Report Number
    2916714-2015-00025
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    December 12, 2014
    Report Date
    January 13, 2015
    Manufacturer
    AESCULAP AG & CO. KG.
    Product Code
    GEI
    PMA / PMN Number
    NARRATIAVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K/PMA# K001330/K003608. MANUFACTURING SITE EVALUATION: DHR HAS BEEN CHECKED AND WAS FOUND TO BE ACCORDING TO THE SPECIFICATIONS. NO OTHER COMPLAINTS WITHIN THIS BATCH ON FILE. MOST LIKELY MECHANICAL OVERLOAD CAUSED THE CERAMIC BREAKAGE. FAILURE IS MOST LIKELY USER RELATED. THERE ARE NO INDICATIONS OF MATERIAL OR PRODUCT DEVIATIONS. INVOLVED COMPONENTS: PM973R. NO DEVIATIONS FOUND; DID NOT CONTRIBUTE TO BREAKAGE. PM450R. NO DEVIATIONS FOUND; DID NOT CONTRIBUTE TO BREAKAGE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CERAMIC BROKE IN SURGERY. THERE IS A POSSIBILITY THAT A PART OF CERAMIC REMAINED IN PATIENT'S BODY. THIS PRODUCT WAS PURCHASED ON (B)(6) 2012 AND IT WAS USED OVER THE RECOMMENDED USAGE TIMES. THOUGH THERE IS A POSSIBILITY THAT THE CAUSE OF BREAKAGE IS A RELATED TO AGING DEGRADATION. INVOLVED COMPONENTS: PM9734/INSULATED OUTER TUBE 5/5MM 310MM. PM450R/HANDLE FOR BIPOLAR INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29928 JAW INS. BIP.MARYLAND DISS.FEN.5/310MM BIPOLAR FORCEPS, HGI GEI AESCULAP AG & CO. KG. PM438R 51871740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other