BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 19913929 · Received August 5, 2024

    Report

    Report Number
    3006524618-2024-00303
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    UDI-DI
    00817470000016
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6, MEDICAL DEVICE PROBLEM CODE WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION ALONG WITH TWO OTHER DEVICES. A VISUAL INSPECTION REVEALED NO MANUFACTURING ABNORMALITIES. THE ELECTRODE ON ALL THREE DEVICES HAVE BEEN USED, BIO DEBRIS IS PRESENT, AND THE DEVICES WERE RETURNED OUT OF THE ORIGINAL PACKAGING (NO PACKAGING RETURNED). A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICES AND FOUND ALL PRODUCED AN E7 ERROR WHEN THE WAND WAS CONNECTED AFTER THE CONTROLLER WAS POWERED ON. A BYPASS BOX WAS USED TO TEST THE DEVICES, AND FOR DEVICE ONE, COAGULATION AND PLASMA WERE GENERATED AS INTENDED (THE RESISTANCE WAS MEASURED AT 1.40 KILO OHMS). THE DEVICE TWO GENERATED AN E6 ERROR (THE RESISTANCE WAS MEASURED AT 1.61 KILO OHMS). FOR DEVICE THREE, COAGULATION AND PLASMA WERE GENERATED AS INTENDED (THE RESISTANCE WAS MEASURED AT 1.40 KILO OHMS). A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE HAS BEEN ASSOCIATED WITH A COMPONENT FAILURE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE A SHORT IN THE WAND OR A DAMAGED T/C WIRE BETWEEN THE TRANSITION OF THE HANDLE AND THE SHAFT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2 DEVICES FROM LOT: 2151656 AND A THIRD UNKNOWN LOT NUMBER. HOWEVER, IT IS UNKNOWN WHICH OF THE 3 DEVICES CONTRIBUTED WITH THE DELAY GREATER THAN 30 MINUTES. D4, EXP. DATE: EXPIRATION DATE IS: 16-APR-2027 (2151656). H4, MGF. DATE: MANUFACTURING DATE IS: 16-APR-2024 (2151656).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THREE AMBIENT SUPER TURBOVAC 90 WANDS FAILED. THE FIRST WAND WAS CONNECTED TO THE CONTROLLER AND DID NOT WORK. THE OTHER TWO WERE CONNECTED AND WORKED INITIALLY, BUT QUICKLY STOPPED WORKING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635356 AMBIENT SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION UNKNOWN 00817470000016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown