BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR MACRO FORCEPS D:5/ 310MM

    MDR report key: 4674042 · Received April 6, 2015

    Report

    Report Number
    2916714-2015-00292
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K): K001330/K003608. PROD WAS NOT PROVIDED FOR INVESTIGATION. THE FAILURE OCCURRED INTRA-OPERATIVELY. IF A POSSIBLE PRE-DAMAGE MIGHT HAVE BEEN RECOGNIZABLE BEFORE THE SURGERY IS UNCLEAR. A FINAL REASON FOR THE CERAMIC BREAKAGE CANNOT BE DETERMINED. ALL BIPOLAR INSTRUMENTS ARE CHECKED BEFORE SALE. THEREFORE WE EXCLUDE A MFG RELATED ERROR. THERE ARE NO HINTS FOR MATERIAL OR PROD DEVIATIONS. MOST LIKELY A MECHANICAL OVERLOAD SITUATION LET TO THE FAILURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INTRA-OPERATIVE BREAKAGE OF CERAMIC DURING LYMPHADENECTOMY. FRAGMENT WAS NOT FOUND. NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225876 BIPOLAR MACRO FORCEPS D:5/ 310MM BIPOLAR FORCEPS, GEI/HGI GEI AESCULAP AG & CO KG PM403R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other