BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK VAPR COOLPULSE 90 ELECTRODE

    MDR report key: 3891218 · Received June 24, 2014

    Report

    Report Number
    1221934-2014-00262
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 27, 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

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION REVEALS THAT THE CERAMIC PORTION OF THE DISTAL TIP IS CRACKED AND A SECTION IS CONFIRMED AS MISSING. THERE IS LITTLE EROSION OF THE ACTIVE TIP INDICATING THAT THE DEVICE HAS HAD LITTLE USE. THERE IS A MARK IN THE HEATSHRINK APPROXIMATELY 1 CM PROXIMAL TO THE DISTAL EDGE OF THE DEVICE WHICH APPEARS TO BE FROM A SHARP OBJECT. IT CAN BE CONFIRMED THAT THE CERAMIC COMPONENT IS CRACKED AND HAS A SECTION MISSING FROM THE DEVICE. THE REASON FOR THIS OCCURRING IS UNKNOWN FROM THE EVIDENCE PRESENTED. THE ADDITIONAL MARKING ON THE HEATSHRINK INDICATES POSSIBLE MISUSE ALTHOUGH THIS CANNOT BE CONFIRMED. IT IS ALSO POSSIBLE THAT THE CERAMIC COMPONENT HAD A FAULT PRIOR TO ACTIVATION OCCURRING, ALTHOUGH THIS CANNOT BE CONFIRMED FROM THE EVIDENCE PRESENTED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH NO INCIDENTS AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY (B)(4) COMPLAINTS SYSTEM REVEALED ONE OTHER DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE OVERALL RATE FOR THIS ISSUE, AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY (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.

    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. IN TRANSIT.

    Description of Event or Problem · 1

    THE ELECTRODE FALL IN ERROR MODE. BREAKAGE OF ELECTRODE CERAMIC TIP OUT OF THE PATIENT AFTER FEW MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER LIKE DEVICE, THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED FROM OUR AFFILIATE ON (B)(6) 2014 INDICATES THE TYPE OF PROCEDURE WAS UNKNOWN, EXCESSIVE FORCE WAS NOT USED ON THE DEVICE, AND THE PIECE OF DEVICE THAT FELL INTO THE PATIENT WAS NOT REMOVED.

    Description of Event or Problem · 1

    THE ELECTRODE FALL IN ERROR MODE. BREAKAGE OF ELECTRODE CERAMIC TIP OUT OF THE PATIENT AFTER FEW MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER LIKE DEVICE, THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED FROM OUR AFFILIATE ON 6-3-14 INDICATES THE TYPE OF PROCEDURE WAS UNKNOWN, EXCESSIVE FORCE WAS NOT USED ON THE DEVICE, AND THE PIECE OF DEVICE THAT FELL INTO THE PATIENT WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367763 MITEK VAPR COOLPULSE 90 ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1312097

    Patients

    Seq Age Sex Outcome Treatment
    1