BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5

    MDR report key: 19245966 · Received May 6, 2024

    Report

    Report Number
    1045254-2024-00657
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 6, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    UDI-DI
    00643169588127
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: BEARINGS CORRODED AND CABLE BROKEN. 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 DURING OPERATION, BUR WOBBLES. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE BUR CONNECTED WITH ANOTHER HANDPIECE AND IT WORKED FINE AND HANDPIECE CONNECTED WITH ANOTHER BLADE/BUR AND IT DEOS NOT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767744 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I ERL MEDTRONIC XOMED INC. 1899200 226423199 00643169588127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown