BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEREWOLF FLOW 90 COBLATION WAND

    MDR report key: 9227084 · Received October 23, 2019

    Report

    Report Number
    3006524618-2019-00522
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 30, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K183346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE FLOW 90 WAND, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. COMPLAINT HISTORY REVIEW SHOWS NO COMPLAINTS ASSOCIATED TO LOT 2022786. DHR/BATCH RECORD REVIEW SHOWS NO NCRS OR DEVIATIONS ASSOCIATED TO LOT NUMBER 2031596 AND RELEVANT TO THE COMPLAINT. CLINICAL EVALUATION WAS COMPLETED AND CONCLUDED THAT BASED ON THE PRODUCT ANALYSIS, THE ROOT CAUSE OF THE WAND BREAKAGE CANNOT BE CONCLUDED AT WHAT POINT OR THE CAUSE OF THE BROKEN TIP. THE PLASTIC TIP IS NOT AN IMPLANTABLE MATERIAL AND LONG TERM ISSUES ARE UNKNOWN. IT IS ALSO UNKNOWN, IF MICROMOTION OR MIGRATION OF THE BIT WILL OCCUR. AS STATED ABOVE NO X-RAYS OR OPERATIVE REPORTS WERE PROVIDED. VISUAL EVALUATION SHOWS THE DEVICE SPACER SEVERELY DAMAGED WITH INDICATIONS THAT A SIDE LOAD WAS APPLIED TO THE DEVICE TIP, AND THE ELECTRODE IS MISSING AND THE ELECTRODE LEG IS BROKEN AT THE BASE. THERE ARE SIGNS OF ACTIVATION FURTHER AFTER MECHANICAL DAMAGED OCCURRED AS THERE IS OXIDATION ON THE BORDER OF THE SHAFT¿S DISTAL END. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED. FUNCTIONAL EVALUATION IS NOT POSSIBLE DUE TO THE TIP¿S DAMAGE. THE COMPLAINT HAS BEEN VISUALLY VERIFIED AND THE ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY; HOWEVER, AFTER INSPECTION OF THE DEVICE THE MOST PROBABLE CAUSE IS CONTACT WITH A SURFACE AT HIGH FORCE CREATING CRACKS IN THE SPACER AND SHEARING THE ELECTRODE AT THE LEG BASE RESULTING IN TIP DETACHMENT. OTHER POTENTIAL FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDES: MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE OR USING THE DEVICE AS A LEVER TO ENLARGE A SURGICAL SITE OR GAIN ACCESS TO TISSUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY PROCEDURE. THE WAND HAD JUST BEEN PUT INTO THE HIP AND WAS USED FOR THE FIRST TIME ON THE ABLATION SETTING, AFTER ROUGHLY A FEW MINUTES OF USE THE PLASTIC CAME AWAY FROM THE WAND. THE SURGEON REMOVED THE WAND FROM THE JOINT AND IT WAS UNSUCCESSFUL IN RETRIEVING THE PIECE OF PLASTIC FROM THE PATIENT'S HIP JOINT. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS 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
    1023859 WEREWOLF FLOW 90 COBLATION WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 2031596

    Patients

    Seq Age Sex Outcome Treatment
    1