BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN JEWELERS BIPOLAR FORCEPS

    MDR report key: 5147823 · Received October 8, 2015

    Report

    Report Number
    3000719969-2015-00001
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    October 22, 2014
    Report Date
    October 7, 2015
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K884656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLSEN MEDICAL DID NOT RECEIVE THE DEVICE BACK; HOSPITAL REP (NURSE STAFF) CALLED SYMMETRY TO MAKE THEM AWARE OF THE INCIDENT, STAFF STATED: SURGEON ERROR. SYMMETRY THOUGHT THIS WAS FILED WITH FDA - COULD NOT LOCATE THE REPORT - RE-FILING.

    Description of Event or Problem · 1

    SURGEON WAS FAMILIAR WITH USING INSULATED FORCEPS, HE USED A NON-INSULATED FORCEPS IN A SURGERY, THE FORCEPS TOUCHED PATIENT ON THE EAR, NO SERIOUS INJURY TO THE PATIENT. FACILITY STATED: SURGEON ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668846 OLSEN JEWELERS BIPOLAR FORCEPS GEI OLSEN MEDICAL 20-1060K

    Patients

    Seq Age Sex Outcome Treatment
    1