BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA HP COBLATOR II

    MDR report key: 11784711 · Received May 6, 2021

    Report

    Report Number
    3006524618-2021-00567
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    March 14, 2021
    Report Date
    May 6, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470004595
    PMA / PMN Number
    K070374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE: (B)(4). THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. THE ELECTRODE HAS EXTENSIVE EROSION AND SMALL PIECE MISSING. THE DEVICE WAS PLUGGED INTO THE CONTROLLER AND REGISTERED SETTINGS (7,3). THE WAND WAS ABLE TO GENERATE PLASMA AS INTENDED. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS THE PACKAGING AND CONFIRMS PART NUMBER EIC5874-01 AND LOT NUMBER 2031730 WITH A PARTIALLY DETACHED ELECTRODE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) HITTING THE DEVICE TIP AGAINST A HARD SURFACE. (2) USING THE DEVICE AS A LEVER TO ENLARGE SURGICAL SITE (3) MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE. (4)ACTIVATING THE DEVICE ABOVE RECOMMENDED SETTINGS FOR PROLONGED PERIODS OF TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE METAL ELECTRODE WIRE IN THE EVAC 70 XTRA HP COBLATOR II WAS FUSING WHEN IT WAS USED FOR 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS, USING A BACKUP DEVICE. NO PATIENT INJURY OR ANY OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE ELECTRODE OF THIS UNIT HAS EXTENSIVE EROSION AND HAS PIECES DETACHED WHICH MAKES IT A REPORTABLE EVENT. 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
    679928 EVAC 70 XTRA HP COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 2031730 00817470004595

    Patients

    Seq Age Sex Outcome Treatment
    1