BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 20406823 · Received October 9, 2024

    Report

    Report Number
    3006544299-2024-00757
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 26, 2024
    Report Date
    December 6, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: THE LEFT TRACKER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT UNABLE TO CONFIRM REPORTED COMPLAINT. INSTALLED TRACKER LEFT IN TWO DIFFERENT KNOWN IMAGING SYSTEMS. THE SYSTEM INITIALIZED. MOTION, GENERATOR, COMMUNICATION AND CHARGING READIED. IMAGING SYSTEM WAS INTERFACED WITH NAVIGATION SYSTEM. 2D AND 3D IMAGES WERE SUCCESSFUL AND IMAGERS TRANSFERRED TO NAVIGATION SYSTEM SUCCESSFULLY. VISUAL INSPECTION CONFIRM PINCH WIRES. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000218, SERIAL/LOT #: 230419 REV. 1, UBD: , UDI#: 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID BI71000218 (LOT: -); PRODUCT ID BI71000568 (LOT: -) H3, H6: A MEDTRONIC REPRESENTATIVE (REP) WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT AFTER TRACKER CALIBRATION, THE VERIFICATION STILL FAILED. THE REP REPLACED THE LEFT SIDE TRACKER, AND COMPLETED TRACKER CALIBRATION AND TRACKER VERIFICATION FOR BOTH 20 CM AND 40 CM FOV ON LEFT SIDE. THE SYSTEM WAS THEN PERFORMING AS INTENDED. CODES B01, C07 AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 TWO SPINS WERE TAKEN AND BOTH SCANS WERE OFF BY 5MM IN THE LATERAL AND SUPERIOR. THE MANUFACTURING REPRESENTATIVE (REP) REPORTED V DRAPE WAS USED, FRAME DID NOT MOVE, AND THE PERCUTANEOUS PIN WAS USED FOR FRAME ATTACHMENT. THIS RESULTED IN A SURGICAL DELAY OF LESS THAN ONE HOUR. MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54544 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female