BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 21987960 · Received May 8, 2025

    Report

    Report Number
    1221934-2025-01695
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 8, 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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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: D9, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED 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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THAT THE DEVICE IS SHOWN COVERED WITH A TRANSPARENT PLASTIC. THE DEVICE'S TIP SHOWS CHARRED. NO OTHER ANOMALIES WERE FOUND. 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 INVESTIGATION FINDINGS, A POTENTIAL CAUSE CANNOT BE ESTABLISHED. MULTIPLE FACTORS ARE ASSOCIATED WITH THIS TYPE OF FAILURE, AND THE COMPLAINT DEVICE NEEDS TO BE PHYSICALLY RECEIVED AND EVALUATED TO DETERMINE A POTENTIAL CAUSE OF WHY THE CUSTOMER EXPERIENCED THE FAILURE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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:

    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: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DEVICE'S TIP IS CHARRED. THE SHAFT WAS FOUND BENT. THE CABLE AND THE SUCTION TUBE WERE CUT BY THE CUSTOMER, AND THEY WERE NOT RETURNED. THE DEVICE WILL BE SENT TO THE MANUFACTURER FOR FURTHER ANALISYS. MANUFACTURING INVESTIGATION RESULT FOR VAPR S90 4.0MM W/INTEGR HDP -EA: THE DEVICE WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. TIP IS USED, SIGNIFICANT DAMAGE ON THE LOWER MANIFOLD. THE HANDLE IS IN USED CONDITION, NO MISUSE. NO CABLE OR SUCTION TUBE FITTED. SHAFT HAS BEEN BENT TO APPROXIMATELY 60 DEGREES. ELECTRICAL CHECKS: NOT CONDUCTED DUE TO NO PLUG BEING FITTED. FUNCTIONAL CHECKS: NOT CONDUCTED DUE TO NO PLUG BEING FITTED. THE CUSTOMER REPORTED "IT WAS REPORTED THAT DURING THE OPERATION, THE HEAD END OF RF SHEAR BURNS SPONTANEOUSLY, SPARKING AND FLAMING, RESULTING IN BLACK AND CHARRED HEAD END" 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 CAPA INVESTIGATION. BASED ON THE EVIDENCE SHOWN IN THE BELOW PHOTOGRAPHS OF CHARRING AND MELTING AT THE MANIFOLD, THE LIKELY CAUSE OF THIS FAILURE IS SHORTING AT THE DISTAL TIP. THIS FAILURE MODE IS CONSISTENT WITH PREVIOUS ONE PIECE LPS ELECTRODES WHICH EXHIBIT SIMILAR FAILURES, INCLUDING THE OUTPUT SHORTING. THESE WERE INVESTIGATED FURTHER IN CAPA. TO ELIMINATE A RECURRENCE OF THIS FAILURE MODE, A DESIGN CHANGE WAS RECOMMENDED. THE COMPLAINT FAILURE MODE HAS BEEN REVIEWED AGAINST THE SYSTEMS RISK ASSESSMENT DOCUMENT, WHICH HAS BEEN RECORDED IN THE SPREADSHEET, '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 =210-4). IN THE LAST 12 MONTHS (JULY 2024 ¿JUNE 2025) 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 THIS DEVICE SHOWS THIS DEFECT TO BE OF LOW OCCURRENCE WITH A TOTAL OF 13 CONFIRMED COMPLAINT DEVICES INCLUDING THIS COMPLAINT DEVICE, WHICH EQUATES TO A FAILURE RATE OF (B)(4) DEVICE SALES. OUR ANALYSIS SHOWS THAT THE FREQUENCY IS WITHIN THE ANTICIPATED RATE OF FAILURE. THE RISK IS DEEMED MINOR, AND NO FURTHER ACTION IS REQUIRED. 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. PLEASE REFER TO CAPA REPORT FOR INFORMATION ON RECOMMENDED ACTIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VAPR S90 4.0MM W/INTEGR HDP -EA WOULD HAVE CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL 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. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    THIS IS REPORT 1 OF 2 OF(B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE VAPR S90 4.0MM W/INTEGR HDP -EA DEVICE SPARKS. THE HEAD END OF RF SHEAR BURNS SPONTANEOUSLY, SPARKING AND FLAMING RESULTING IN THE BLACK AND CHARRED HEAD END. THE USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY HOWEVER THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794355 VAPR S90 4.0MM W/INTEGR HDP -EA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI DEPUY MITEK LLC US U2307091 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown