BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 8903500 · Received August 16, 2019

    Report

    Report Number
    3006524618-2019-00403
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 23, 2019
    Report Date
    February 29, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470000016
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10:H3,H6: THE AMBIENT SUPER TURBOVAC 90 IFS WAND, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. FROM THE INFORMATION PROVIDED, ¿DURING A SHOULD ARTHROSCOPY, THE CONSOLE SHOWED AN ERROR MESSAGE, "HANDPIECE PAST EXPIRATION". IN FACT, THE WAND WAS WITHIN EXPIRATION PERIOD AND IT WAS USED WITH THE PATIENT.¿ A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2028141 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES. VISUAL EVALUATION SHOWS NO WEAR ON THE ELECTRODES. NO MANUFACTURING DISCREPANCIES OBSERVED. DURING FUNCTIONAL EVALUATION THE DEVICE WAS CONNECTED INTO A QUANTUM2 CONTROLLER AND REGISTERED AN E-7 ERROR. THE ERROR WAS BY-PASSED AND THE DEVICE PERFORMED AS INTENDED. THE SUCTION TUBE WAS TESTED AND PERFORMED AS SPECIFIED. THE COMPLAINT WAS VERIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. FACTORS THAT COULD HAVE LED TO THE ERROR MESSAGE INCLUDES: THE WAND INCORPORATES A SINGLE-USE FEATURE WHICH IS DESIGNED TO PREVENT REUSE OF THE WAND. THE RF CONTROLLER MAY HAVE BEEN TURNED OFF FOLLOWING CONNECTION OF THE WAND OR SOURCE POWER MAY HAVE BEEN INTERRUPTED PRIOR TO WAND ACTIVATION. OTHER FACTORS THAT COULD CONTRIBUTE TO THE ERROR INCLUDE REUSING THE DEVICE OR DISCONNECTING THE DEVICE FROM THE CONTROLLER AFTER POWER HAS BEEN TURNED ON, PREVIOUS USE OR INCORRECT POWER CYCLING OF THE CONTROLLER. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. WE CANNOT DETERMINE IF THERE IS A RELATIONSHIP BETWEEN THE DEVICE AND THE INCIDENT BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. HANDPIECE PAST EXPIRATION ERROR (E3) INDICATES THAT THE WAND WAS CONNECTED BEYOND ITS EXPECTED USE TIME, IT IS NOT AN INDICATOR FOR SHELF LIFE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULD ARTHROSCOPY, THE CONSOLE SHOWED AN ERROR MESSAGE, "HANDPIECE PAST EXPIRATION". IN FACT, THE WAND WAS WITHIN EXPIRATION PERIOD AND IT WAS USED WITH THE PATIENT. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694428 AMBIENT SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4250-01 2028141 00817470000016

    Patients

    Seq Age Sex Outcome Treatment
    1