BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS BASE STATION

    MDR report key: 14024541 · Received April 6, 2022

    Report

    Report Number
    1818910-2022-05756
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 29, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519515
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION, WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED, THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DESCRIBED FAILURE BY THE CUSTOMER WAS CONFIRMED. ROOT CAUSE SUMMARY: BASED ON THE EVENT DESCRIPTION, AND ENGINEERING REVIEW THE ROOT CAUSE CAN BE DETERMINED, TO BE RELATED TO A THE ROBOT CABLE. WHICH WAS CONFIRMED, TO HAVE AN INTERMITTENT UNINTENTIONAL SHORT. THIS ISSUE HAS BEEN ESCALATED TO A CAPA. REVIEW OF THE DEVICE RECORDS, INDICATES THAT THERE WERE NO ISSUES, DURING THE INSTALLATION OF THIS PRODUCT. WHICH, WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE, DUE TO DESIGN.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. UDI:(B)(4). DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ROBOT ASSISTED BASE STATION DEVICE HAD AN ELECTRICAL SHORT IN THE CABLE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488444 VELYS BASE STATION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-100 10603295519515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown