BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE

    MDR report key: 5944979 · Received September 12, 2016

    Report

    Report Number
    1221934-2016-10378
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 15, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K122425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED FOR EVALUATION AND THEREFORE THE REPORTED FAILURE CANNOT BE VERIFIED. IT CANNOT BE DETERMINED IF THE ACTIVE TIP SUSTAINED ANY DAMAGE THAT LED TO THIS TYPE OF FAILURE. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTRO SURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. THE MAJORITY OF ARTHROSCOPES AND ARTHROSCOPIC INSTRUMENTS ARE METAL. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ IT WAS REPORTED THE ELECTRODE WAS USED FOR 2 MINUTES BEFORE FAILING AND IT WAS NOT NEAR ANY METAL. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE 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 MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE COMPLAINT RATES WERE REVIEWED AGAINST THE RISK ANALYSIS DOCUMENTS AND FOUND TO BE WITHIN EXPECTED LEVELS. SINCE THE FUNCTION OF THE ELECTRODE IS TO ABLATE TISSUE, THE RISK ASSOCIATED WITH SPARKING OF THE ELECTRODE TIP WITHIN THE JOINT SPACE IS LOW. DEPUY 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. (B)(4).

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A KNEE PROCEDURE THE CUSTOMER'S VAPR S90 4.0MM ELECTRODE WITH INTEGRATED HANDPIECE SHORTED OUT AND ARCED IN THE PATIENT'S JOINT. THE SALES REP REPORTED THAT THE DEVICE WAS ON FOR APPROXIMATELY TWO MINUTES BEFORE THE ISSUE OCCURRED AND WAS BEING USED INTERMITTENTLY. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE (UNKNOWN IF FROM THE SAME LOT NUMBER) WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE GENERATOR SETTINGS WERE SET AT DEFAULT 220/140 AND NEPTUNE WAS USED FOR SUCTION. THE SALES REP STATED THAT THE DEVICE WAS NOT NEAR METAL AND WAS ACTIVATED IN SALINE BEFORE USE. THE SALES REP CONFIRMED THAT THE ELECTRODE IS A BRAND NEW DEVICE AND NOT REPROCESSED. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595778 VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE VAPR ELECTRODES GEI DEPUY MITEK U1603088

    Patients

    Seq Age Sex Outcome Treatment
    1