BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5813871 · Received July 21, 2016

    Report

    Report Number
    2916714-2016-00575
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 20, 2016
    Report Date
    July 21, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K001330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. ADDITIONAL PROCODE / 510(K): HGI / K003608.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. DURING THE OPERATION FOR NEPHRECTOMY, THE JAW BECAME UNSTABLE AND THE SURGEON FOUND THAT THE GRAY CERAMIC IS BROKEN. 2 PIECES OF BROKEN PARTS WERE COLLECTED OUTSIDE OF THE PATIENT BODY. X RAY WAS NEGATIVE FOR RETAINED PIECES. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466938 JAW INS.BIP.MARYLAND DISS.FEN.5/310MM DISSECTING FORCEPS GEI AESCULAP AG PM438R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other