BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM2000 ELECTROSURG.

    MDR report key: 7510908 · Received May 14, 2018

    Report

    Report Number
    1216677-2018-00026
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 18, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BR FILED. (B)(4). UPDATE 5/18/2018: INVESTIGATION: A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS SIMILAR ISSUES. THE UNIT WAS FOUND TO OPERATE TO SPECIFICATIONS WITH NO DEVIATIONS. THIS UNIT WAS IN SERVICE SINCE 2012 WITH NO RECORD OF A PRIOR ISSUE/RETURN. THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE UNIT WAS FOUND TO FUNCTION WELL SO NO WEAR AND TEAR APPEARS TO BE PLAYING A ROLL IN THE OCCURRENCE. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS NOT READILY AVAILABLE. IT IS NOT CLEAR IF THE ISSUE WAS DUE TO END USER ERROR, BUT IT IS LIKELY SOME ERROR DURING THE PROCEDURE HAD OCCURRED NOT RELATED TO THE DEVICE'S FUNCTION.

    Description of Event or Problem · 0

    REVIEW OF REPAIR LOG (B)(4). CUSTOMER RESPONDED THE FOLLOWING IN THE REPAIR AUTHORIZATION FORM: DID THE PHYSICIAN PERFORM EXTRA STEPS TO COMPLETE THE PROCEDURE? YES - STITCH, CHEMICAL COATING. WAS THERE A POTENTIAL HEALTH RISK? YES.

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BR FILED. REFERENCE E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    REVIEW OF REPAIR LOG 88639. CUSTOMER RESPONDED THE FOLLOWING IN THE REPAIR AUTHORIZATION FORM: DID THE PHYSICIAN PERFORM EXTRA STEPS TO COMPLETE THE PROCEDURE? YES - STITCH, CHEMICAL COATING. WAS THERE A POTENTIAL HEALTH RISK?YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355755 QUANTUM2000 ELECTROSURG. QUANTUM2000 ELECTROSURG. HGI COOPERSURGICAL, INC. 909075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention