BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM2000 ELECTROSURG.

    MDR report key: 8501001 · Received April 10, 2019

    Report

    Report Number
    1216677-2019-00048
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    January 2, 2019
    Report Date
    December 12, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4). INVESTIGATION: X-REVIEW DHR, X-INSPECT RETURNED SAMPLES, ANALYSIS AND FINDINGS: A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS NO SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS NO ANOMALIES. THIS UNIT WAS CONVERTED TO A DEMO UNIT ON WO #242590. THE COMPLAINT COULD NOT BE CONFIRMED. THE UNIT WAS RETURNED DAMAGED. LOOSE AND BROKEN PARTS WERE VIEWABLE WHEN THE COVER WAS OPENED UP. NO ADDITIONAL INVESTIGATION WAS POSSIBLE. THIS UNIT HAD SHIPPED OUT DECEMBER 2018 AND RETURNED FEBRUARY 6, 2019. THIS UNIT WAS FULLY INTACT AND FUNCTIONAL WHEN CONVERTED TO A DEMO UNIT. THIS DAMAGE EITHER OCCURRED DURING POSSESSION BY THE END USER OR IN TRANSIT TO AND FROM FG. A ROOT CAUSE FOR THIS COMPLAINT CONDITION IS NOT DEFINITIVELY DETERMINED. HOWEVER, ANY DEFECTIVE FUNCTION OBSERVED IS BEING ATTRIBUTED TO DAMAGE. CORRECTION AND/OR CORRECTIVE ACTION: NONE. THE UNIT WAS PROCESSED FOR SCRAP. COMPLAINTS WILL BE CONTINUOUSLY MONITORED TO DETERMINE IF THERE IS ANY NEW TREND FOR THIS COMPLAINT CONDITION. THIS COMPLAINT WILL BE ENTERED INTO THE COOPERSURGICAL CONTINUOUS IMPROVEMENT PLAN (CIP). WAS THE COMPLAINT CONFIRMED? NO. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    REVIEW OF REPAIR ORDER LOG 90862. CUSTOMER STATED: "LEEP MACHINE JUMPS FROM COAGULATION TO CUT. NOT CAUTERIZING FAST ENOUGH AND UNABLE TO GET ABOVE 35. " REF. (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS INVESTIGATING THE REPORTED COMPLAINT CONDITION. (B)(4).

    Description of Event or Problem · 1

    REVIEW OF REPAIR ORDER LOG (B)(4). CUSTOMER STATED "LEEP MACHINE JUMPS FROM COAGULATION TO CUT. NOT CAUTERIZING FAST ENOUGH AND UNABLE TO GET ABOVE 35. " (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295341 QUANTUM2000 ELECTROSURG. QUANTUM2000 ELECTROSURG. HGI COOPERSURGICAL, INC. 909075 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other