BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 6131866 · Received November 29, 2016

    Report

    Report Number
    1216677-2016-00064
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    September 12, 2016
    Report Date
    November 10, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CONCLUDES COOPERSURGICAL' S ROOT CAUSE INVESTIGATION. COOPERSURGICAL, INC. WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR TENDING AND SAFETY.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WAS RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). "ON DEPRESSING THE FOOT PEDAL, THE MACHINE GIVES AN OUTPUT FOR FEW SECONDS AND THEN THERE IS NO OUTPUT (POWER) AT ALL. SAME THING HAPPENS WITH CUT AND CAUTERY. IN SPITE OF HAVING THE FOOT PEDAL DEPRESSED THE MACHINE DOES NOT PROVIDE AN OUTPUT AFTER A FEW SECONDS. " (B)(4).

    Description of Event or Problem · 1

    REVIEW OF REPAIR ORDER LOG (B)(4). "ON DEPRESSING THE FOOT PEDAL, THE MACHINE GIVES AN OUTPUT FOR FEW SECONDS AND THEN THERE IS NO OUTPUT (POWER) AT ALL. SAME THING HAPPENS WITH CUT AND CAUTERY. IN SPITE OF HAVING THE FOOT PEDAL DEPRESSED, THE MACHINE DOES NOT PROVIDE AN OUTPUT AFTER A FEW SECONDS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783429 LEEP SYSTEM 1000 ESU GEN. LEEP SYSTEM 1000 ESU GEN. HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other