BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4436266 · Received January 14, 2015

    Report

    Report Number
    2916714-2015-00026
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    October 29, 2014
    Report Date
    January 14, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K001330
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2015. ADD'L PMA/ 510 (K) # K003608. MANUFACTURING SITE EVAL: BREAKAGE OF CERAMIC IS RESULT OF TWISTING AND/OR BENDING OF INSTRUMENT OR BY EXCESSIVE MECHANICAL FORCES DURING PROCESSING / HANDLING. DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE ACCORDING TO SPEC. THERE ARE NO INDICATIONS OF PRODUCT OR MATERIAL DEVIATIONS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE CUSTOMER FOUND THE BREAKAGE WHEN USING DURING SURGERY. THE CUSTOMER COULD NOT DETECT THE EXACT TIME OF THE BREAKAGE. THERE IS THE POSSIBILITY OF INTRA-OPERATIVE BREAKAGE DURING PREVIOUS SURGERY. "USAGE" USED FOR PINPOINT COAGULATION ONLY. NEVER TWISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33547 JAW INS. BIP. MARYLAND DISS. FCPS 5/310MM BIPOLAR FORCEPTS GEI AESCULAP AG & CO. KG PM431R 52030527

    Patients

    Seq Age Sex Outcome Treatment
    1 Other