BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 10906951 · Received November 25, 2020

    Report

    Report Number
    3000719969-2020-00007
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    September 2, 2020
    Report Date
    November 25, 2020
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785113369
    PMA / PMN Number
    K111262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT ABLE TO PROVIDE PICTURES, THE LOT NUMBER, OR RETURN THE DEVICE FOR EVALUATION. WITHOUT THIS INFORMATION THE DEVICE HISTORY RECORD CANNOT BE REVIEWED AND A TRUE ROOT CAUSE CANNOT BE DETERMINED. THERE HAS BEEN A TOTAL OF 2,828 SOLD OF THIS CORD SINCE 2016 WITH 4 ADDITIONAL COMPLAINTS RECORDED FOR SIMILAR OCCURRENCES. IN EACH OCCURRENCE, THE DEVICE WAS EITHER NOT RETURNED FOR EVALUATION OR THE ROOT CAUSE WAS DETERMINED TO BE WEAR AND TEAR OF THE CORD. THE IFU FOR THIS PRODUCTS RECOMMENDS A TWENTY USES. DUE TO THE LACK OF INFORMATION, THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ADDITIONAL PATIENT INVOLVEMENT OR THE NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT A FIRE STARTED WHILE THE SURGEON WAS USING AN L-HOOK ATTACHED TO THE MONOPOLAR CORD USING A COVIDIEN VALLEYLAB FT10 DURING THE SURGERY. THE CORD FRAYED NEAR THE PLASTIC END, CAME OFF, FELL INTO THE POCKET OF THE DRAPE AND STARTED THE FIRE. THE FIRE WAS EXTINGUISHED WITHIN SECONDS. THERE WAS NO HARM TO THE PATIENT OR THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372152 CONMED MONOPOLAR CORD GEI OLSEN MEDICAL LLC 60-5169-001 00841785113369

    Patients

    Seq Age Sex Outcome Treatment
    1