BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENT MR8

    MDR report key: 21559469 · Received March 10, 2025

    Report

    Report Number
    1625507-2025-00742
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    October 18, 2023
    Report Date
    March 10, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00763000356965
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION DETERMINED THAT THE DEVICE WAS OVERHEATING AND THE TEMPERATURE WAS MEASURED TO BE 125.2 DEGREES FAH RENHEIT. THE LIKELY CA USE WAS IDENTIFIED AS BEARING DAMAGED. IT WAS ALSO NOTED THAT CORROSION. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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

    IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254383 ENT MR8 MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS 1847ATTSS 00763000356965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown