BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2441858 · Received February 2, 2012

    Report

    Report Number
    1717344-2012-00094
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Report Date
    January 30, 2012
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT GENERATOR HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE UNIT IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A SPINAL PROCEDURE WAS PERFORMED, AN EEG PAD WAS DESCRIBED AS BEING BUBBLED IN APPEARANCE. WHEN THE PAD WAS REMOVED FROM THE PT'S ANKLE, THE SKIN WAS REMOVED ALONG WITH THE PAD. AN UNK TYPE OF COVIDIEN RETURN ELECTRODE HAD BEEN PLACED ON THE PT THIGH DURING THE PROCEDURE. THERE WAS NO INJURY AT THE SITE WHERE THE COVIDIEN RETURN ELECTRODE WAS PLACED. THE SITE HAS TESTED THE INCIDENT GENERATOR AND THE UNIT TESTED SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EEG RETURN ELECTRODE - LOT #UNK| UNK TYPE OF COVIDIEN RETURN ELECTRODE: LOT #UNK