BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    MDR report key: 18961819 · Received March 22, 2024

    Report

    Report Number
    1045254-2024-00405
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 23, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    UDI-DI
    00643169350687
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3: CORRECT 510K IS K041413. 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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS COULD NOT VERIFY EXCESSIVE HEAT. BECAUSE OF CORRSION ON REAR SEALS, BEARINGS AND SHAFT NOT RUNNING. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRA OP DEVICE WAS OVERHEATING. THERE IS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523806 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I ERL MEDTRONIC XOMED INC. 1898200T 211435655 00643169350687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown