BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR TRIPOLAR 90 SUCTION ELECT

    MDR report key: 7655877 · Received July 2, 2018

    Report

    Report Number
    1221934-2018-52790
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 5, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705023103
    PMA / PMN Number
    K143475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE NOT AVAILABLE FOR A PHYSICAL EVALUATION. IT WAS REPORTED THAT THE SURGEON HAD THE DEVICE BURIED IN TISSUE AND THE SALES REP TOLD THE SURGEON NOT BURY THE ELECTRODE IN TISSUE BUT THE SURGEON STILL DID IT. THIS HAS BEEN KNOWN TO CAUSE SUCTION FAILURES. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE SUCTION DEFECT OR THE DEFECT WITH THE METAL TIP FALLING OFF OF THE ELECTRODE HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE. THIS COMPLAINT CANNOT BE CONFIRMED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT, AS THIS FAILURE WAS NOT CONFIRMED, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S VAPR TRIPOLAR 90 SUCTION ELECTRODE WAS CLOGGING AND WHEN THE SURGEON PULLED THE DEVICE OUT OF THE PATIENT THE METAL TIP POPPED OFF. THE SALES REP CONFIRMED THAT THE TIP DID NOT FALL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE GENERATOR SETTINGS WERE SET AT 260/130, THE DEVICE WAS USED INTERMITTENTLY, AND NEPTUNE WAS USED FOR SUCTION. THE SALES REP STATED THAT THE SURGEON DID HAVE THE DEVICE BURIED IN TISSUE AND HAS TOLD THE SURGEON TO NOT BURY THE ELECTRODE IN TISSUE BUT STILL DOES IT. UNKNOWN HOW LONG THE DEVICE WAS IN USE BEFORE THE CLOGGING BEGAN. THE SALES REP STATED THAT THE TIP AND ELECTRODE WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496321 VAPR TRIPOLAR 90 SUCTION ELECT ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US U1801198 10886705023103

    Patients

    Seq Age Sex Outcome Treatment
    1