BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK VAPR COOL PULSE ELECTRODE W/HAND CONTROLS

    MDR report key: 4123100 · Received September 26, 2014

    Report

    Report Number
    1221934-2014-00427
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 15, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. AWAITING DEVICE RETURN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMED THE DISTAL CERAMIC PORTION OF THE TIP IS CRACKED AND SECTIONS ARE MISSING. THERE IS LITTLE EROSION OF THE ACTIVE TIP INDICATING THAT THE DEVICE HAS HAD LITTLE USE. THE REASON FOR THIS OCCURRING IS UNKNOWN FROM THE EVIDENCE PRESENTED. THERE IS NO OBVIOUS ADDITIONAL DAMAGE FROM A DROPPING OR MISUSE EVENT. IT IS ALSO POSSIBLE THAT THE CERAMIC COMPONENT HAD A FAULT PRIOR TO ACTIVATION OCCURRING, ALTHOUGH THIS CANNOT BE CONFIRMED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW INTO THE COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE COMPLAINT HISTORY FOR SUCH FAILURE, AT THIS POINT NO FURTHER ACTION IS WARRANTED. HOWEVER, (B)(4) WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    ELECTRODE CERAMIC TIP BREAKAGE IN THE BONE. DURING AN ANKLE ARTHROSCOPY, A FRAGMENT OF THE MITEK PROBE WAS FOUND IN THE JOINT BY THE SURGEON. THE FRAGMENT, VERY SMALL AND MOBILE, DIDN'T HAVE BEEN ABLE TO BE RECOVERED. HE HOPES THAT THERE IS NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    ELECTRODE CERAMIC TIP BREAKAGE IN THE BONE. DURING AN ANKLE ARTHROSCOPY, A FRAGMENT OF THE MITEK PROBE WAS FOUND IN THE JOINT BY THE SURGEON. THE FRAGMENT, VERY SMALL AND MOBILE, (B)(4) HAVE BEEN ABLE TO BE RECOVERED. HE HOPES THAT THERE IS NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601129 MITEK VAPR COOL PULSE ELECTRODE W/HAND CONTROLS ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1401129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other