BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY GUIDE

    MDR report key: 19222365 · Received May 1, 2024

    Report

    Report Number
    1723170-2024-01181
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    March 8, 2024
    Report Date
    May 1, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00681490991520
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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: 960-539, SERIAL/LOT #: (B)(6)) THE INSTRUMENT (PRODUCT ID: 960-539) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AFTER VISUAL/PHYSICAL EXAMINATION, THE REPORTED ISSUE WAS CONFIRMED. THE RESULTS CONCLUDED THAT THE PIVOT PIN AT THE TOP JOIN HAD BEEN BROKEN OFF. AS A RESULT, THE GUIDE HAS NO ANCHOR POINT AND MOVES UNRESTRAINED. CODES: B01, C07, D02 G2) FOREIGN COUNTRY: JAPAN 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 A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THE CERVICAL PROBE ACCURACY COULD NOT BE ACHIEVED. THE BIOPSY GUIDE WOULD MOVE, EVEN WHEN IT WAS LOCKED. THERE WAS A FOREIGN OBJECT IN THE HOLLOW OF THE SOLERA. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154372 BIOPSY GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 960-539 030210 00681490991520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown