BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 10513661 · Received September 10, 2020

    Report

    Report Number
    3006524618-2020-00742
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 18, 2020
    Report Date
    October 15, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE DEVICE SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. VISUAL INSPECTION OF THE DEVICE SHOWED MINIMAL EROSION OF THE SCREEN/ELECTRODES AND SOME DISCOLORATION OAF THE SPACER. THE DEVICE WAS CONNECTED TO A KNOWN GOOD CONTROLLER WHICH DISPLAYED AN "E7 ERROR". THE DEVICE WAS THEN CONNECTED TO THE KNOWN GOOD CONTROLLER USING A BYPASS BOX, WHICH REVEALED THE DEVICE PERFORMED AS INTENDED. THE SUCTION LINE PERFORMED AS INTENDED. THE COMPLAINT WAS VERIFIED AS THE DEVICE DISPLAYED AN E7 ERROR. THE ROOT CAUSE WAS DETERMINED TO BE REUSE OF A SINGLE USE DEVICE. FACTORS, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT INCLUDE: (1) PREVIOUS USE (2) DISCONNECTING THE WAND FROM THE CONTROLLER AFTER POWER HAS BEEN TURNED ON. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROTATOR CUFF ARTHROSCOPY, WHEN THE AMBIENT SUPER TURBOVAC WAS CONNECTED, THE CONSOLE SHOWED AN ERROR 7 CODE, AFTER SEVERAL ATTEMPTS TO GET IT TO WORK, THE RADIO FREQUENCY WAS DISCONNECTED AND RECONNECTED BUT THIS TIME THE CONSOLE SHOWED AN ERROR 8 CODE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. 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
    983343 AMBIENT SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 2051383

    Patients

    Seq Age Sex Outcome Treatment
    1