BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM2000 ELECTROSURG.

    MDR report key: 8595297 · Received May 9, 2019

    Report

    Report Number
    1216677-2019-00070
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    February 6, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. SERVICE & REPAIR DID NOT CONFIRM THE COMPLAINT. THE UNIT FUNCTIONED TO SPECIFICATIONS FREE OF FUNCTIONAL DEFECTS. THE OUTPUT WAS CONFIRMED TO BE WITHIN SPECIFICATIONS AND THERE WERE NO LEAKAGE ERRORS. THIS UNIT WAS FOUND TO FUNCTION BUT LATER FOUND TO FALL UNDER RECALL #1216677-05-24-2019-002-R FOR A POTENTIAL FOR C21 TO SHORT OUT DUE TO EXCESSIVE CURRENT ABOVE THE COMPONENT'S RATING. A DIODE WILL ADDRESS THE ISSUE AND CAN BE PUT IN PLACE ONCE THE UNIT IS RETURNED VIA THE RECALL. *CORRECTION AND/OR CORRECTIVE ACTION: NONE. THE UNIT WAS CONFIRMED TO FUNCTION TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THIS UNIT WAS DETERMINE TO BE ON THE RECALL LIST. THE CUSTOMER WILL BE MADE AWARE OF THE ISSUE AND REQUEST THE UNIT BE RETURNED FOR THE APPROPRIATE UPDATE TO THE DISPLAY BOARD. *WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "COAG TOO LOW WHEN UNIT IS COLD, AFTER WARMUP COAG CLOSE TO NORMAL". REFERENCE REPAIR ORDER: 91289 REF. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "COAG TOO LOW WHEN UNIT IS COLD, AFTER WARMUP COAG CLOSE TO NORMAL". REFERENCE REPAIR ORDER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387173 QUANTUM2000 ELECTROSURG. QUANTUM2000 ELECTROSURG. HGI COOPERSURGICAL, INC. 909075 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other