BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSAPH PLUS, WITH RADIAL

    MDR report key: 16410420 · Received February 21, 2023

    Report

    Report Number
    1124841-2023-00052
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 20, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    GEI
    UDI-DI
    00699753450769
    PMA / PMN Number
    K160206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON FEBRUARY 21, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H6: (IDENTIFICATION OF EVALUATION CODES 10, 3259, 19). TYPE OF INVESTIGATION: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. INVESTIGATION FINDINGS: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 19 - CAUSE TRACED TO USER. THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT TO CONFIRM ONE SIDE OF THE V-CUTTER WAS BROKEN OFF. THE CONDITION OF THE RETURNED SAMPLE DID NOT ALLOW FOR ELECTRICAL TESTING. A RETENTION SAMPLE WAS NOT ABLE TO BE OBTAINED AS THE LOT NUMBER WAS NOT PROVIDED. DURING THE MANUFACTURING PROCESS, ALL VSP550 UNITS ARE VISUALLY INSPECTED AND TESTED FOR FUNCTIONALITY AND PERFORMANCE ALONG WITH INSPECTION FOR V-CUTTER MECHANISM, PRIOR TO PACKAGING. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. COMPONENT CODE: 777 - CUTTER/BLADE. 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: 1069 - BREAK. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE CUTTER CAME RIGHT OUT OF THE DEVICE WHEN IN USE. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644194 VIRTUOSAPH PLUS, WITH RADIAL LAPAROSCOPE, GENERAL GEI TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VSP550EX UNKNOWN 00699753450769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown