BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 19655556 · Received July 2, 2024

    Report

    Report Number
    3005075696-2024-00074
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OWB
    UDI-DI
    00763000132378
    PMA / PMN Number
    K200074
    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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000192. H6: MULTIPLE ANNEX A CODES WERE CODED FOR THIS EVENT. A090501 WAS CODED FOR THE SYSTEM NOT EXPOSING. A1102 WAS CODED FOR THE PENDANT SAYING "DOOR OPEN." A150204 WAS CODED FOR THE DOOR NOT CLOSING. H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD AND THE ROTOR WAS OUT OF ALIGNMENT. THE MANUFACTURER REPRESENTATIVE (REP) REALIGNED THE ROTOR AND THE ISSUE WAS RESOLVED. B01, C07, AND D02 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GANTRY DOOR WAS UNABLE TO CLOSE FULLY. THE SITE REPORTED THE DOOR WOULD REACH "97%" OF THE WAY CLOSED, THEN STOPPED WITH A SMALL VISIBLE GAP BETWEEN THE DOORS. THE PENDANT REPORTED "DOOR OPEN" AND COULDN'T EXPOSE. THE SITE USED THE ANOTHER IMAGING SYSTEM FOR THE REMAINDER OF THE PROCEDURE. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800685 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MAZOR ROBOTICS LTD BI70002000 00763000132378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown