BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 22113563 · Received May 30, 2025

    Report

    Report Number
    1221934-2025-01977
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 16, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    GEI
    UDI-DI
    10886705009398
    PMA / PMN Number
    K082643
    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: INVESTIGATION SUMMARY: 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'S TIP IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ACROMIOPLASTY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR S90 4.0MM W/INTEGR HDP ELECTRODE DEVICE SPARKED DURING USE. IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS BURNT BLACK. 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
    35637 VAPR S90 4.0MM W/INTEGR HDP -EA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDOS INTERNATIONAL SARL U2407009 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown