BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 9706697 · Received February 13, 2020

    Report

    Report Number
    3006524618-2020-00054
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 22, 2020
    Report Date
    March 20, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470000016
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS MINIMAL ELECTRODE AND SCREEN WEAR. DURING FUNCTIONAL EVALUATION THE DEVICE WAS CONNECTED TO A COMPATIBLE QUANTUM2 CONTROLLER AND DID NOT WORK. AN ERROR E-7 OCCURRED. AN ERROR E-2 AS REPORTED WAS NOT INDICATED DURING THE TESTS. THE SUCTION LINE WAS TESTED AND PERFORMED AS INTENDED. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF MANUFACTURING RECORDS FOR THIS L/N 2031766 FOUND NO DEVIATIONS OR NON-CONFORMANCE'S DURING THE MANUFACTURING PROCESS. THE COMPLAINT WAS NOT VERIFIED AS THE DEVICE PERFORMED AS SPECIFIED AFTER BYPASSING THE E-7 ERROR. THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. POTENTIAL FACTORS UNRELATED TO THE DESIGN AND MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE ERROR E-2 INCLUDE (1) DEFECTIVE CABLING/PERIPHERALS (2) DAMAGED CONTROLLER. THERE ARE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUPER T-VAC DISPLAYED AN E2 ERROR WHEN CONNECTED TO A QUANTUM II. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168352 AMBIENT SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4250-01 2031766 00817470000016

    Patients

    Seq Age Sex Outcome Treatment
    1