BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS, WITH RADIAL

    MDR report key: 17781476 · Received September 20, 2023

    Report

    Report Number
    1124841-2023-00228
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 20, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    GEI
    UDI-DI
    00699753450769
    PMA / PMN Number
    K160206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT TO CONFIRM A BURNED AND BROKEN V-CUTTER. THE CONDITION OF THE RETURNED SAMPLE DID NOT ALLOW FOR ELECTRICAL TESTING. A RETENTION SAMPLE WAS PREVIOUSLY INSPECTED TO SHOW NO ANOMALIES WITH THE DEVICE AND A FULLY INTACT V-CUTTER. IT WAS THEN ELECTRICALLY TESTED WITH NO ANOMALIES WITH THE DEVICE WERE FOUND AND ALL ELECTRICAL TESTS WERE WITHIN SPECIFICATION. DURING THE MANUFACTURING PROCESS, ALL VSP550 ARE VISUALLY INSPECTED AND TESTED FOR FUNCTIONALITY AND PERFORMANCE ALONG WITH INSPECTION FOR V-CUTTER MECHANISM, PRIOR TO PACKAGING. COMPONENT CODE: 3039 - CAUTERY TIP. HEALTH EFFECT ¿ IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT. HEALTH EFFECT ¿ CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 1198 - ELECTRICAL/ELECTRONIC PROPERTY PROBLEM. TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. TYPE OF INVESTIGATION #2: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER. TYPE OF INVESTIGATION #3: 3331 - ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS: 120 - ELECTRICAL PROBLEM IDENTIFIED. INVESTIGATION CONCLUSIONS: 19 - CAUSE TRACED TO USER. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    TERUMO CARDIOVASCULAR WAS INFORMED ON JULY 21, 2023 THAT DURING VEIN HARVESTING, THE TIP DID NOT WORK WHEN USING IT TO SEAL THE VESSELS. THE DEVICE WAS REPLACED WITH A NEW PRODUCT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO BLOOD LOSS, AND NO PATIENT EFFECT. UPON INVESTIGATING THE RETURNED SAMPLE ON (B)(6) 2023, IT WAS DISCOVERED THAT THE V-CUTTER COMPONENT WAS BURNT AND BROKEN. TERUMO CONSERVATIVELY ASSUMES THAT THE COMPONENT WAS BURNT WHILE IN CONTACT WITH THE PATIENT, THUS POTENTIALLY CAUSING AN INJURY. WITH THIS DISCOVERY, THIS EVENT IS NOW CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626490 VIRTUOSAPH PLUS, WITH RADIAL LAPAROSCOPE, GENERAL GEI TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VSP550EX 23K 00699753450769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other