BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM ENT STRAIGHT SUCTION

    MDR report key: 20926427 · Received December 13, 2024

    Report

    Report Number
    1723170-2024-03913
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    March 5, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA (B)(4). F26: NO PATIENT IMPACT F1908: 30 SECOND DELAY A0709: INTERMITTENT TRACKING A05: BENT SUCTION H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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 INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING REGISTRATION, THE INSTRUMENT PROVIDED INTERMITTENT TRACKING. WHEN THE OPERATING ROOM TEAM SWAPPED FOR A SECOND STRAIGHT SUCTION, THE SYSTEM FUNCTIONED AS INTENDED. ALL OTHER INSTRUMENTS FUNCTIONED NORMALLY. NO FURTHER TROUBLESHOOTING COULD BE COMPLETED AT TIME OF THE CALL. PATIENT IMPACT UNKNOWN. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE COULDN'T GET THEIR STRAIGHT NAVIGATED SUCTION TO REGISTER. THEY HAD ANOTHER SET IN THE ROOM THAT SET REGISTERED IMMEDIATELY. THE SUCTION WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414765 EM ENT STRAIGHT SUCTION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733449 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown