BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 19102963 · Received April 14, 2024

    Report

    Report Number
    1045254-2024-00538
    Event Type
    Malfunction
    Date Received
    April 14, 2024
    Date of Event
    January 27, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL INFORMATION SUGGEST THAT B17 AND D16 NO LONGER APPLY TO THIS EVENT. 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 DURING PRE-OP, THE TOOL BIT JAMMED INSIDE THE SKEETER HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION STATES THAT BUR WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832552 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNKNOWN BUR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown