BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS MBS W/ LIGHT

    MDR report key: 21572853 · Received March 11, 2025

    Report

    Report Number
    1723170-2025-01249
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    March 7, 2025
    Report Date
    March 11, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEI
    PMA / PMN Number
    K073495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES B17, C20 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE, A HOLE WAS FOUND IN THE TUBING OF THE HANDPIECE UPON OPENING THE PACKAGING. THERE WAS NO DELAY IN THE SURGERY AND NO IMPACT ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309664 AQUAMANTYS MBS W/ LIGHT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI MEDTRONIC NAVIGATION, INC 23-301-1 -

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown