BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SATELLITE STATION

    MDR report key: 13621284 · Received February 28, 2022

    Report

    Report Number
    1818910-2022-03766
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 28, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519492
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL NARRATIVE: 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). CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, ARRAY CLAMP DEVICES, (B)(6) 2022.

    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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. INVESTIGATION SUMMARY: THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS UNABLE TO BE DUPLICATED OR CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 5 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THE FEMORAL CUTS WERE OFF WHILE THE SATELLITE STATION DEVICE WAS IN USE. FOLLOWING THE SURGERY, IT WAS REPORTED THAT THE CLINICIAN PULLED ON THE FEMORAL ARRAYS AND OBSERVED THAT THE ARRAY DEVICES DETACHED FROM THE ARRAY CLAMPS WITHOUT PRESSING THE BUTTON RELEASE ON THE ARRAY CLAMP DEVICES. IT WAS REPORTED THAT THERE WERE A TOTAL OF FOUR ARRAY CLAMPS THAT RELEASED THE ARRAY WITHOUT PRESSING THE BUTTON. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672576 VELYS SATELLITE STATION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-101 10603295519492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown