BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 21750184 · Received April 2, 2025

    Report

    Report Number
    1221934-2025-01192
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 2, 2025
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009398
    PMA / PMN Number
    K082643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H11 ADDITIONAL NARRATIVE: DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION REVELED THAT THE MANIFOLD SHOW A CHARRED SECTION. THE DEVICE WAS SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION. THE SUPPLIER PERFORMED AN EVALUATION WITH THE FOLLOWING RESULTS: THE TIP IS USED, SIGNIFICANT USAGE TO ACTIVE TIP. CERAMIC CRACKED WITH EXCESSIVE DAMAGE ON THE LOWER MANIFOLD. HANDLE, CABLE AND PLUGS ASSEMBLIES ARE IN GOOD CONDITION. DEVICE FAILED HIPOT ACTIVE-RETURN ELECTRICAL CHECK. ACTIVATION WAS NOT CONDUCTED DUE TO MANIFOLD STATE. THE VISUAL EXAMINATION REVEALED 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 PRECISE ROOT CAUSE CANNOT BE PINPOINTED. NOTE THAT SIMILAR DAMAGE HAS BEEN SEEN ON THE PLASTIC MANIFOLD UNDER A CAPA. DURING TESTING AT ATL UK WE WERE ABLE TO CONFIRM A FAULT WITH 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 CAPA. TO ELIMINATE RECURRENCE OF THIS FAILURE MODE A DESIGN CHANGE IS REQUIRED. THE COMPLAINT FAILURE MODE HAS BEEN REVIEWED AGAINST THE SYSTEMS RISK ASSESSMENT DOCUMENT, WHICH IS INCORRECT OR INAPPROPRIATE OUTPUT OR FUNCTIONALITY' RESULTING IN AN INTERNAL ARCING OF INSTRUMENT. THE RISK LEVEL SEVERITY IS CATEGORIZED AS MINOR AND ALRA (AS LOW AS REASONABLY ACHIEVABLE). THE CURRENT PROBABILITY LEVEL IS 'PROBABLE'. COMPLAINT RATES WILL CONTINUE TO BE MONITORED THROUGH STANDARD COMPLAINT REVIEW CHANNELS. AS DETAILED IN CONTROL PLAN, ONE PIECE LPS ELECTRODES ARE 100% INSPECTED FOR FUNCTIONALITY AS PART OF THEIR PRODUCT TEST REGIME THEREFORE ALL REASONABLE CONTAINMENT IS STILL IN PLACE. BASED ON A REVIEW OF THE INVESTIGATION FINDINGS, CURRENT PROCESS CONTROLS IN PLACE AND THE PRODUCT RISK ANALYSIS DOCUMENT NO CONTAINMENT OR CORRECTION ACTION RELATED TO THE INDIVIDUAL COMPLAINT IS REQUIRED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VAPR S90 4.0MM W/INTEGR HDP-EA WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL ROOT CAUSE IS TRACED TO DEVICE DESIGN. THIS PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION BY THE SUPPLIER. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE SUPPLIER QUALITY SYSTEM. J&J MEDTECH ORTHOPAEDICS WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    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. D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    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. H11 ADDITIONAL NARRATIVE: D4: THE DEVICE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. E1: THE INITIAL REPORTER'S COMPLETE FACILITY ADDRESS WAS NOT PROVIDED. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND AN ARTHROSCOPIC IMAGE IN WHICH WAS NOTED THAT A SECTION OF THE MANIFOLD IS CHARRED. THE SUPPLIER PERFORMED AN EVALUATION WITH THE FOLLOWING RESULTS: THE EVENT DESCRIPTION OF THE BLADE LEAKING ELECTRICITY WOULD INDICATE A SPARKING/ARCING EVENT WHICH IS FURTHER EVIDENCED BY THE CHARRED MANIFOLD SECTION AT THE TIP OF THE ELECTRODE. 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. THE ASSIGNABLE ROOT CAUSE WAS IDENTIFIED AS A DESIGN ISSUE, WHICH WAS ESCALATED TO CAPA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE VAPR S90 4.0MM W/INTEGR HDP DEVICE BLADE WAS LEAKING ELECTRICITY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745506 VAPR S90 4.0MM W/INTEGR HDP -EA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI DEPUY MITEK LLC US U2405064 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown