BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA HP COBLATOR II

    MDR report key: 10942737 · Received December 3, 2020

    Report

    Report Number
    3006524618-2020-01055
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 9, 2020
    Report Date
    February 16, 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 · 0

    H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. NO VISUAL ISSUES WERE OBSERVED. THE DEVICE WAS PLUGGED INTO THE CONTROLLER AND REGISTERED SETTINGS (7,3). THE WAND WAS ABLE TO GENERATE PLASMA AS INTENDED. 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. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS THE PACKAGING AND CONFIRMS PART NUMBER EIC5874-01 WITH LOT NUMBER 2022139. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. REFERENCE: CASE-(B)(4).

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE EVAC 70 EXTRA WAND DID NOT GENERATE PLASMA. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY. NO INJURIES WERE 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
    1405438 EVAC 70 XTRA HP COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. EIC5874-01 2022139 00817470004595

    Patients

    Seq Age Sex Outcome Treatment
    1