BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM2000 ELECTROSURG.

    MDR report key: 4956089 · Received July 29, 2015

    Report

    Report Number
    1216677-2015-00038
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    February 12, 2015
    Report Date
    May 19, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    COOPERSURGICAL, INC. REPAIR LOG NUMBER (B)(4). A RETROSPECTIVE REVIEW OF THE REPORTED COMPLAINT CONDITION: "INADEQUATE CHARGE NOT CONSISTENTLY CUTTING OR CAUTERIZING". INDICATES A PRODUCT MALFUNCTION WHICH COULD POSSIBLY NECESSITATE INTERVENTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493365 QUANTUM2000 ELECTROSURG. QUANTUM2000 GEI COOPERSURGICAL, INC. 909075

    Patients

    Seq Age Sex Outcome Treatment
    1