BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE XP COBLATOR II

    MDR report key: 19877114 · Received July 31, 2024

    Report

    Report Number
    3006524618-2024-00296
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 6, 2024
    Report Date
    September 2, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    UDI-DI
    00817470000368
    PMA / PMN Number
    K202006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. AN EVALUATION OF THE CUSTOMER PROVIDED (IMAGE/VIDEO) WAS PERFORMED AND FOUND A DIFFERENT DEVICE THAN THE ONE REPORTED ON A PLASTIC TRAY, A EVAC 70 XTRA HP (EIC5874-01, LN 2112249). THE DEVICE IDENTIFICATION INFORMATION IS NEXT TO IT. THERE WAS NO CLARIFICATION IF THIS DEVICE FAILED OR IF IT IS RELATED WITH THE REPORTED EVENT. 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. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE THE PROCISE COBLATOR WAND WAS UNABLE TO ACTIVATE. THERE WAS A BACK UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740893 PROCISE XP COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION 2124616 00817470000368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown