BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEREWOLF RF 20000 CONTROLLER

    MDR report key: 10207169 · Received June 29, 2020

    Report

    Report Number
    3006524618-2020-00421
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    January 1, 1901
    Report Date
    July 29, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00885556624890
    PMA / PMN Number
    K162074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION ON G4 (PMA/510(K)NUMBER): K162074.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND OBSERVED NO ISSUES. A FUNCTIONAL EVALUATION REVEALED NO PROBLEMS. A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THERE ARE 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 FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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. THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE "WEREWOLF CONTROLLER" DID NOT RECOGNIZE THE WAND. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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
    670482 WEREWOLF RF 20000 CONTROLLER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 72290105 00885556624890

    Patients

    Seq Age Sex Outcome Treatment
    1