BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD

    MDR report key: 8633823 · Received May 22, 2019

    Report

    Report Number
    1717344-2019-00666
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Report Date
    May 22, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524001531
    PMA / PMN Number
    K110268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED SAMPLE DID NOT MEET SPECIFICATION AS RECEIVED BY MEDTRONIC. THE VISUAL INSPECTION FOUND NO DEFECTS. THERE WAS NO PATIENT INVOLVED. THE INVESTIGATION FOUND THAT DURING THE TEST (CROSS COUPLING), WHEN MONOPOLAR 1 WAS ACTIVATED - MONOPOLAR 2 WAS MEASURED, FULL POWER WAS MEASURED FOR MONOPOLAR 2. THE INVESTIGATION IDENTIFIED THE CAUSE OF THE REPORTED EVENT TO BE THE RELAY BOARD. THE RELAY BOARD WAS REPLACED TO ADDRESS THE CONDITION. MIF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING SERVICING, THE UNIT HAD A DEFECTIVE SR BOARD COMPONENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425583 FORCETRIAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCETRIAD 10884524001531

    Patients

    Seq Age Sex Outcome Treatment
    1