BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 21873979 · Received April 21, 2025

    Report

    Report Number
    1221934-2025-01406
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    February 23, 2025
    Report Date
    April 21, 2025
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009398
    PMA / PMN Number
    K082643
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: E1: THE REPORTER¿S COMPLETE FACILITY NAME WAS NOT PROVIDED INVESTIGATION SUMMARY ==> THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT WAS IN A USED CONDITION AND WAS NOT RETURNED IN ITS PACKAGING, THE ACTIVE TIP HAD SIGNS OF ACTIVATION. THE SHAFT, HANDLE, CABLE AND PLUG DID NOT SHOW ANY SIGNS OF DAMAGE. A FUNCTIONAL TEST WAS PERFORMED BY CONNECTING THE DEVICE TO A TEST GENERATOR, AS A RESULT, IT WAS FOUND THAT AN OUTPUT SHORT ERROR CODE WAS DISPLAYED WHEN ACTIVATING THE ABLATION AND INTERMITTENTLY FOR THE COAGULATION FUNCTION USING THE FOOT PEDAL. THE ELECTRODE WILL BE SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. THE SUPPLIER PERFORMED AN EVALUATION WITH THE FOLLOWING RESULTS: DEVICE WAS RECEIVED ONLY IN THE OUTER CARTON, THE TIP HAD SIGNIFICANT USE AND EXCESSIVE DAMAGE ON THE LOWER MANIFOLD, NO OTHER ANOMALIES COULD BE OBSERVED ON THE DEVICE. THE DEVICE FAILED HIPOT ACTIVE RETURN ELECTRICAL TESTING, ALSO ACTIVATION FUNCTIONAL TESTING WAS NOT CONDUCTED DUE TO THE STATE OF THE MANIFOLD. THE VISUAL INSPECTION FOUND THAT THE PLASTIC MANIFOLD IS SEVERELY MELTED AT THE PROXIMAL REGION OF THE MANIFOLD WHICH WAS LIKELY DAMAGED BY MISUSE OR A 'SHORTING' EVENT. THE SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. NOTE THAT SIMILAR DAMAGE HAS BEEN SEEN AT DIFFERENT LOCATION AT PROXIMAL END OF THE PLASTIC MANIFOLD UNDER CAPA INVESTIGATION. THE COMPLAINT DEVICE HAS BEEN RETURNED FOR FURTHER INVESTIGATION. DURING TESTING THE FAULT WITH THE DEVICE WAS CONFIRMED. THE COMPLAINT DEVICE WAS FOUND TO FAIL ELECTRICAL TESTING (HIPOT ACTIVE ¿ RETURN). FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. BASED ON THE EVIDENCE OF THE CHARRED AND BURNT SECTION OF THE MANIFOLD SEEN FOR THE RETURNED ELECTRODE, THE LIKELY CAUSE OF THIS FAILURE IS SHORTING AT DISTAL TIP. THE FAILURE MODE SEEN IS CONSISTENT WITH PREVIOUS ONE PIECE LPS ELECTRODES (S90) WHICH EXHIBIT SIMILAR FAILURE MODES INCLUDING OUTPUT SHORTING, MANIFOLD MELTING, SPARKING AND ARCING DURING A SURGICAL PROCEDURE AND HAVE BEEN FURTHER INVESTIGATED THROUGH CAP. IT WAS DETERMINED THAT THE ISSUE WAS DUE TO A DESIGN ERROR, WHICH HAS BEEN ESCALATED TO A CAPA. THE COMPLAINT FAILURE MODE HAS BEEN REVIEWED AGAINST THE SYSTEMS RISK ASSESSMENT DOCUMENT, 'HAZARD TYPE - INCORRECT OR INAPPROPRIATE OUTPUT OR FUNCTIONALITY' RESULTING IN AN INTERNAL ARCING OF INSTRUMENT. THE HAZARDOUS SITUATIONS ANNOTATED FOR THIS FAILURE MODE ARE 'INSUFFICIENT RF ENERGY DELIVERED' WITH A POTENTIAL OUTCOME (S) / HARM BEING 'INCORRECT TISSUE EFFECT'. THE RISK LEVEL SEVERITY IS CATEGORIZED AS MINOR AND ALRA (AS LOW AS REASONABLY ACHIEVABLE). THE CURRENT PROBABILITY LEVEL IS 'PROBABLE' (<10¯3 AND =10¯4). IN THE LAST 12 MONTHS A TOTAL (B)(4) INDIVIDUAL ONE PIECE LPS ELECTRODES WERE SHIPPED. A REVIEW OF OUR COMPLAINT RECORDS OVER THE LAST 12 MONTHS TO ASSESS THE FREQUENCY OF THIS DEFECT FOR DEVICE (225370) SHOWS THIS DEFECT TO BE OF LOW OCCURRENCE WITH A TOTAL OF 16 CONFIRMED COMPLAINT DEVICES INCLUDING THIS COMPLAINT DEVICE, WHICH EQUATES TO A FAILURE RATE OF 1 IN (B)(4) WHICH IS AS ANTICIPATED IN THE RISK ANALYSIS. OUR ANALYSIS SHOWS THAT THE FREQUENCY IS BELOW THE ANTICIPATED RATE OF FAILURE DETAILED IN THE RA RISK MANAGEMENT DOCUMENT (B)(4) AND THE RISK IS DEEMED MINOR AND NO FURTHER ACTION IS REQUIRED. COMPLAINT RATES WILL CONTINUE TO BE MONITORED THROUGH STANDARD COMPLAINT REVIEW CHANNELS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VAPR S90 4.0MM W/INTEGR HDP -EA WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE.¿ BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE POTENTIAL CAUSE IS TRACED TO DESIGN. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH SUPPLIER QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE U2403076, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS CLEANING PROCEDURE, IT WAS DISCOVERED THAT THE VAPR S90 4.0MM W/INTEGR HDP DEVICE WAS ABLE TO PERFORM COAGULATION ONLY, AND NOT ABLATION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A MELTED MANIFOLD. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015892 VAPR S90 4.0MM W/INTEGR HDP -EA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI DEPUY MITEK LLC US U2403076 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown