BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA HP COBLATOR II

    MDR report key: 9374089 · Received November 26, 2019

    Report

    Report Number
    3006524618-2019-00570
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 8, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE RETURNED DEVICE USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. . A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER 2013173 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 FOR LOT NUMBER 2013173 FOR THE PAST 3 YEARS FOUND NO RELATED FAILURES. VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS MODERATE ELECTRODE WEAR. THE SHAFT IS EXTREMELY BENT. THERE WERE NO MANUFACTURING ABNORMALITIES FOUND ON THE RETURNED DEVICE. DURING FUNCTIONAL EVALUATION IN THE LAB, THE RETURNED DEVICE WAS ACTIVATED IN SALINE SOLUTION USING A KNOWN GOOD COBLATOR2 CONTROLLER. THE DEVICE WAS TESTED AT COBLATE/COAGULATE MODE IN STANDARD AND MAXIMUM SETTINGS. PLASMA WAS GENERATED ON THE ELECTRODES AS SPECIFIED. THE SUCTION TUBE WAS TESTED AND PERFORMED AS INTENDED. THE SALINE LINE WAS TESTED WITH A SYRINGE AND PERFORMED AS SPECIFIED. THE COMPLAINT WAS NOT VERIFIED AS THE DEVICE PERFORMED AS SPECIFIED. FACTORS WHICH CAN CONTRIBUTE THE REPORTED ISSUE INCLUDES: (1) LOW SUCTION RATE (2) THE SALINE FLOW WAS TOO LOW; (3) LARGE, ABLATED TISSUE REMNANTS (4) USING EXCESSIVE FORCE. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. ADDITIONAL INFORMATION ON E1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY, THE WAND COULD NOT ABLATE NORMALLY. THE CONTROLLER, FOOT PEDAL AND CONNECTING WIRES WERE CHECK AND NO ABNORMALITY WAS FOUND. THERE WAS A DELAY GREATER THAN 30 MINUTES AND A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES REPORTED. 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
    1168810 EVAC 70 XTRA HP COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 2013173

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR