BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 17760760 · Received September 15, 2023

    Report

    Report Number
    3006544299-2023-00599
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    September 13, 2023
    Report Date
    September 15, 2023
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: BI71000187,  SERIAL/LOT: UNKNOWN. H3, H6) NO PARTS HAVE RETURNED TO THE MANUFACTURER FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING AN ORTHO (THA AND TKA) PROCEDURE. IT WAS REPORTED THAT THE MOBILE VIEWING STATION (MVS) WOULD NOT LET THEM MOVE AROUND IN THE SOFTWARE. THE PATIENT WAS NOT CUT INTO, THEY WERE INTUBATED. THE IMAGING SYSTEM STILL WOULD LET THEM MOVE AROUND IN THE SOFTWARE. THERE WAS TROUBLESHOOTING PRESENT. IT WAS REPORTED THAT THREE HARD RESTARTS WERE PERFORMED. THE SYSTEM WAS UNPLUGGED FROM THE WALL AND THE BLUE LIGHT KEPT BLINKING AND DID NOT SHUT ALL THE WAY OFF. IT WAS JUST BLINKING THE BLUE LIGHT AFTER ABOUT 4 MINUTES. AFTER RESTART, THE MOUSE WAS STILL UNABLE TO BE USED. THE OPTIC LASER ON THE MOUSE DID NOT COME OUT. FUNCTIONS TO TERMINATE THE PROGRAM, THE "ENTER" BUTTON, AND THE OPERATING SYSTEM'S HOME BUTTON DID NOT WORK EITHER. THE DONGLE WAS UNPLUGGED FROM THE SYSTEM AND THE WIRELESS MOUSE WAS ATTEMPTED TO BE USED BUT IT DID NOT WORK. IT WAS REPORTED THAT THE SURGERY, AND BOTH MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED. THERE WAS NO REPORTED IMPACT TO PATIENT'S OUTCOME AND NO SURGICAL DELAY. THE ISSUE WAS RESOLVED ONCE THE WIRELESS MOUSE WAS UNPLUGGED AS IT WAS "CREATING HAVOC" AMONGST THE UNIVERSAL SERIAL BUS (USB) TREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294912 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male SEE H10...