BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS, WITH RADIAL

    MDR report key: 13122229 · Received December 30, 2021

    Report

    Report Number
    1124841-2021-00290
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 6, 2021
    Report Date
    February 18, 2022
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORPORATION
    Product Code
    GEI
    UDI-DI
    00699753450769
    PMA / PMN Number
    K160206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 DECEMBER 30, 2022. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: B5 (ADDED DESCRIBE EVENT OR PROBLEM). G3 (DATE RECEIVED BY MANUFACTURER). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H3 (DEVICE EVALUATION ANTICIPATED BY MANUFACTURER - A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSIONS CODE 11.). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: B2 ( OUT COMES ATTRIBUTED TO ADVERSE EVENT - SERIOUS INJURY). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H1 (TYPE OF REPORTABLE EVENTS - SERIOUS INJURY). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION). H6 (IDENTIFICATION OF EVALUATION CODES 4614, 2925, 10, 11, 3331, 120, 3259, 19). HEALTH EFFECT - IMPACT CODE: 4614 - SERIOUS INJURY/ ILLNESS/ IMPAIRMENT. MEDICAL DEVICE PROBLEM CODE: 2925 - ELECTRICAL POWER 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 FINDING #1: 120 - ELECTRICAL PROBLEM IDENTIFIED. INVESTIGATION FINDINGS #2: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 19 - CAUSE TRACED TO USER. THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT TO CONFIRM A BROKEN AND BURNED V-CUTTER. A RETENTION SAMPLE FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION WAS PREVIOUSLY REVIEWED AND ELECTRICALLY TESTED, UNDER CR-76988. NO ANOMALIES WITH THE DEVICE WERE FOUND AND ALL ELECTRICAL TESTS WERE WITHIN SPECIFICATION. DURING THE MANUFACTURING PROCESS, ALL VSP550EX ARE VISUALLY INSPECTED AND TESTED FOR FUNCTIONALITY AND PERFORMANCE ALONG WITH INSPECTION FOR V-CUTTER MECHANISM, PRIOR TO PACKAGING. BASED ON REVIEW OF PAST COMPLAINTS, THE CRACKED/FRACTURED DISTAL END OF THE V-CUTTER MOST LIKELY RESULTED FROM EXCESSIVE FORCE APPLIED TO THE DISTAL END OF THE V-CUTTER DURING THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, 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.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED INDICATED THAT THE PRODUCT WAS CHANGED, THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT EFFECT OR INJURY. THE APPROXIMATE TIME OF DELAY IS NOT KNOWN AND IS NOT SIGNIFICANT AS THERE WAS NO IMPACT ON THE PROCEDURE OUTCOME.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE PRODUCT CAUTERIZED ON THE INCORRECT SIDE. IT IS UNKNOWN WHETHER THERE WAS DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT, WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY, WHETHER THERE WAS BLOOD LOSS OR ANY PATIENT INJURY DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016186 VIRTUOSAPH PLUS, WITH RADIAL LAPAROSCOPE, GENERAL GEI TERUMO CARDIOVASCULAR SYSTEM CORPORATION VSP550EX 97K 00699753450769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other