BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3883057 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00095
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 17, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K01075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    G5: K010752 : K940936. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CASE: LEFT-SIDED SPONTANEOUS PNEUMOTHORAX: THE SURGEON OPENED THE JAW THREE TIMES IN THE CHEST CAVITY OF THE PATIENT. AT THE THIRD TIME OF THE MOVEMENT OF THE JAW, INSTRUMENT DID NOT FEEL RIGHT, SO HE STOPPED USING IT. AFTER THE SURGERY, MAINTENANCE STAFF NOTICED THAT THE INSIDE OF THE JAW WAS BROKEN. X-RAY PERFORMED, NO RETAINED PIECES WERE VISIBLE. PIECES WERE NOT LOCATED IN THE OPERATING ROOM. THIS DEVICE IS SOLD IN THE US AS COMPLETE DEVICE, PO118R; EVALUATION IS DONE AT COMPONENT LEVEL, AS FOLLOWS: PO624R-JAW INS. DE'BAKEY ATR.FCPS 10MM 370MM, PM977R-INSULATED OUTER TUBE 10/10MM 370MM, PM959R-HANDLE FOR BIPOLAR INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103845 MARYLAND GSP.FORCEPS FEN.5/310MM HF CON. GEI/KNF GEI AESCULAP AG & CO. KG PM408R

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other