BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEREWOLF FLOW 90 COBLATION WAND

    MDR report key: 11613208 · Received April 5, 2021

    Report

    Report Number
    3006524618-2021-00416
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 17, 2021
    Report Date
    December 20, 2023
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00885556647462
    PMA / PMN Number
    K183346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H6: THE SHIPPING INFORMATION WAS PROVIDED; HOWEVER, THE SUBJECT DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT AND THUS A PHYSICAL PRODUCT EVALUATION COULD NOT BE PERFORMED. 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. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES SHOWS THE ORIGINAL PACKAGING FOR FOUR WEREWOLF WANDS PART NUMBER 72290038 AND LOT NUMBERS 2062565, 2066090, 2066080, AND 2063922. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, THE WAND WAS OVERHEATING VERY QUICKLY. BACKUP DEVICES WERE AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT 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
    513577 WEREWOLF FLOW 90 COBLATION WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 72290038 2066080 00885556647462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown