BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 9805309 · Received March 9, 2020

    Report

    Report Number
    1723170-2020-00799
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 27, 2020
    Report Date
    April 16, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D11 ADDITIONAL INFORMATION) LOT NUMBER OF CONCOMITANT PRODUCT: 170505 H3, H6) A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SYSTEM PERFORMED AS INTENDED AND PASSED A SYSTEM CHEC KOUT. THE MICROSCOPE CABLE WAS POTENTIALLY REPLACED, HOWEVER THIS WAS NOT CONFIRMED AT THE TIME OF FILING. 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

    OTHER RELEVANT DEVICE(S) ARE: CABLE 9733823 ZEISS COMBINED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE AT THE TIME IF FILING THIS REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THAT THE RETURNED CABLE WAS FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM FOUND. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION) IT WAS CONFIRMED THAT REPLACING THE MICROSCOPE CABLE RESOLVED THE ISSUE. FDM, FDR, FDC CODES APPLY TO THIS ANALYSIS AS A RESULT RATHER THAN FDR, FDC CODES REPORTED PREVIOUSLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CRANIAL TUMORECTOMY. IT WAS REPORTED THAT THE MICROSCOPE HAD BECOME DISCONNECTED. IT WAS REPORTED THAT A FRACTURE OF THE MICROSCOPE COMMUNICATION CABLE WAS SUSPECTED. ATTEMPT WAS MADE TO RESTART THE MICROSCOPE AND THE NAVIGATION SEVERAL TIMES BUT THE ISSUE WAS NOT RESOLVED. BACK-UP PRODUCTS WERE USED. THERE WAS NO DELAY AND NO IMPACT TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269119 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1