BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 7065116 · Received November 28, 2017

    Report

    Report Number
    1723170-2017-04854
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    October 30, 2017
    Report Date
    April 25, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2) UNIQUE DEVICE IDENTIFICATION (UDI) AND DEVICE MANUFACTURE DATE UPDATED TO PROPER VALUE. THE HANDSWITCH FOR THE IMAGING SYSTEM WAS NOT REPLACED. H6) THE LOGS FOR THE NAVIGATION SYSTEM WERE REVIEWED BY MEDTRONIC PERSONNEL. HOWEVER, THE LOGS PROVIDED NO ADDITIONAL INSIGHT INTO THE PROBABLE CAUSE OF THE ANOMALY. THE SOFTWARE INVESTIGATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH 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 EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS ELECTRONICALLY RESUBMITTED PER FDA REQUEST. IN THIS INSTANCE, THE REPORT FOLLOW-UP SEQUENCE WAS APPARENTLY OUT OF ORDER DUE TO DATA CONVERSION AND LIKELY REDUNDANT, AS THERE IS NO SUBSTANTIVE INFORMATION TO ADD AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO SITE TO TEST THE EQUIPMENT. REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. REPRESENTATIVE NOTED COSMETIC DAMAGE ON HAND SWITCH. AS A PRECAUTION, HAND SWITCH WAS REPLACED. A SYSTEM CHECKOUT WAS PERFORMED AND THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE SUSPECT HAND SWITCH HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE LOGS FOR THE VIEWING STATION OF THE IMAGING SYSTEM WERE REVIEWED BY MEDTRONIC PERSONNEL. IT WAS REPORTED THAT THE IMAGE ACQUISITION SPINNING OPERATION WAS ABORTED DUE TO ERRORS FROM THE MAIN IMAGING SYSTEM. IT WAS NOTED THAT THE VIEWING STATION OF THE IMAGING SYSTEM FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE EVENT REPORTED IN THIS 3500A ALSO REPRESENTS A POTENTIAL ACCIDENTAL RADIATION OCCURRENCE (ARO) PER 21 CFR 1002.20(A). PER 21 CFR 1002.20(C), THIS EVENT IS BEING REPORTED UNDER PART 803. (B)(6). NUMBER OF PERSONS EXPOSED: 1. NUMBER OF PERSONS ADVERSELY AFFECTED: 0. ACTIONS TAKEN TO CONTROL, CORRECT, OR ELIMINATE: SEE NARRATIVE ABOVE AND/OR PREVIOUS MDR SUBMISSIONS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING SPINAL FUSION PROCEDURE, THE IMAGING SYSTEM WAS UNABLE TO PERFORM IMAGE ACQUISITION. NO FURTHER INFORMATION WAS PROVIDED. THE PROCEDURE WAS COMPLETED WITH THE USE OF IMAGING. NO INFORMATION WAS PROVIDED ON DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842576 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON) 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female