BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM ENT STRAIGHT SUCTION

    MDR report key: 22377969 · Received July 1, 2025

    Report

    Report Number
    1723170-2025-02571
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    April 14, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000053369
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN COUNTRY - JAPAN H3, H6: THE 9733449 STRAIGHT SUCTION, LOT NUMBER 231107 WAS RETURNED FOR EVALUATION. ANALYSIS FOUND A FAILURE. THE RETURNED STRAIGHT SUCTION HAD NO APPARENT PHYSICAL DAMAGE BUT WOULD NOT VERIFY WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE SUCTION DISPLAYED A DIVOT ERROR OF 2.5MM TO 2.6MM. CODES B01, C13 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 A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION INSTRUMENT HAD DEFORMATION WHICH WAS CONFIRMED DURING THE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452961 EM ENT STRAIGHT SUCTION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733449 231107 00763000053369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown