BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEREWOLF FLOW 90 COBLATION WAND

    MDR report key: 14438734 · Received May 19, 2022

    Report

    Report Number
    3006524618-2022-00244
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 27, 2022
    Report Date
    February 7, 2023
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00885556647462
    PMA / PMN Number
    K183346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. NO VISUAL ISSUES WERE OBSERVED. PRODUCT WAS OUT OF THE ORIGINAL PACKAGING. NO PACKAGING RETURNED. A REVIEW OF THE CUSTOMER PROVIDED IMAGES SHOWS A CONTROLLER WITH THE "MULTIPLE BUTTON PRESSED NOTIFICATION" ERROR AND THE PACKAGING OF THE WAND CONFIRMING PART NUMBER 72290038 AND LOT NUMBER 2081981. THE DATA EXTRACTED REVEALED THE WAND WAS ACTIVATED PREVIOUSLY AND EXPERIENCED A "MULTIPLE BUTTON PRESSED NOTIFICATION" ERROR. DEVICE WAS TESTED, AND GENERATED PLASMA AND COAGULATION 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 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. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: 1)THE WAND´S CONNECTOR OR CABLE GOT DAMAGED. 2) SALINE/HUMIDITY ENTERED THE INTERIOR OF THE HANDLE SHORTING THE CONNECTION OF THE BUTTONS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR PROCEDURE, AFTER USING FOR SOME TIME, ONCE PRESSED THE WEREWOLF WAND ABLATE YELLOW BUTTON, EVEN THE HAND WAS RELEASED FROM THE WAND, IT WAS STILL ABLATING BY ITSELF. AND ONCE PRESSED THE COAG BLUE BUTTON, THE ERROR SIGN SHOWED ON SCREEN: ¿MULTIPLE BUTTONS HAVE BEEN PRESSED SIMULTANEOUSLY¿ ALTHOUGH FOOT PEDAL WAS NOT PLUGGED AND USED AT THAT POINT OF TIME. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260793 WEREWOLF FLOW 90 COBLATION WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 72290038 2081981 00885556647462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown