BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAW INS.BIP.MACRO FORCEPS D: 5/310MM

    MDR report key: 4351260 · Received December 12, 2014

    Report

    Report Number
    2916714-2014-00931
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    December 5, 2014
    Manufacturer
    AESCULAP AG & CO KG TUTTLINGEN 78532
    Product Code
    GEI
    PMA / PMN Number
    K001330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNITED STATES REPORTING AGENT NOTIFIED ON: (B)(6) 2014. K003608. MFR EVALUATION: PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. SINCE THESE TYPES OF INSTRUMENTS ARE CONTROLLED TO 100% BEFORE GOING TO THE WAREHOUSE, WE ASSUME AN APPLICATION ERROR, CAUSED BY MECHANICAL OVERLOAD. THERE ARE NO HINTS FOR MATERIAL OR PRODUCT DEVIATION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT DESCRIPTION: CERAMIC WAS BROKEN. THERE IS A POSSIBILITY THAT A PART OF CERAMIC IS STILL IN PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810509 JAW INS.BIP.MACRO FORCEPS D: 5/310MM UTILITY FORCEPS: GEI/HGI GEI AESCULAP AG & CO KG TUTTLINGEN 78532 PM433R

    Patients

    Seq Age Sex Outcome Treatment
    1