BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS FOOTPEDAL

    MDR report key: 15655444 · Received October 21, 2022

    Report

    Report Number
    3012236936-2022-02630
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 23, 2022
    Report Date
    March 6, 2023
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474700871
    PMA / PMN Number
    K203060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE EVALUATION: THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE WAS ONSITE DUE TO SYSTEM ADVANCING MODES WITHOUT FOOTPEDAL (FP) BEING ACTIVATED; COULD NOT DUPLICATE ISSUE. SERVICE COMPLETED VERITAS PERFORMANCE CHECKLIST. DEVICE DID NOT FUNCTION AS INTENDED BUT NO FAILURES WERE FOUND DURING EVALUATION. SERVICE REPLACED THE FP PROACTIVELY. VERITAS MEETS JNJ SPECIFICATIONS. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THERE WERE NO DISCREPANCIES OR NON-CONFORMANCES EXPERIENCED DURING MANUFACTURING. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. CONCLUSION: THE DEVICE DID NOT FUNCTION AS INTENDED BUT NO FAILURES WERE FOUND DURING EVALUATION. SERVICE REPLACED THE FP PROACTIVELY. VERITAS MEETS JNJ SPECIFICATIONS. AS A RESULT OF THE TIME OF INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION , INC HAS BEEN SUMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION; SECTION H6 COMPONENT CODE: IN THE INITIAL REPORT THE COMPONENT CODE WAS 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE AND HAS BEEN UPDATED TO READ AS COMPONENT CODE 423 - CABLE, ELECTRICAL. SECTION H3: DEVICE EVALUATION: SERVICE FOUND FOOT PEDAL PASSED SELF-TEST BUT SHOWED ERRORS IN EVENT LOG. ENGINEERING EVALUATED THE FOOT PEDAL AND FOUND THAT THE MODES ARE ADVANCING ON ITS OWN AND THAT THE BT CONNECTION IS INTERMITTENT. ENGINEERING FELT THE CAUSE WAS A BAD CABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION , INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE ACCOUNT REPORTED SYSTEM ADVANCED MODES WITHOUT THE SURGEON ACTIVATING FOOT SWITCH. THE SURGEON WAS OPERATING AND WAS IN THE EPI SETTING WHEN THE MACHINE ADVANCED TO THE IA CORTEX MODE WITHOUT HIM ACTIVATING IT MANUALLY WITH THE FOOT SWITCH. IT HAPPENED MULTIPLE TIMES BUT ONLY ONCE DID HE HAVE PATIENT INJURY RESULTING IN A VITRECTOMY. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE FOOTPEDAL. A SEPARATE REPORT WILL BE SUBMITTED FOR THE VERITAS CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546568 VERITAS FOOTPEDAL UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680700 05050474700871

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention VERITAS CONSOLE S/N (B)(6).