BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 16262682 · Received January 30, 2023

    Report

    Report Number
    1045254-2023-00074
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 30, 2023
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00721902755057
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: VISUALLY, THERE WAS NO EXTERNAL DAMAGE IN THE CONSTRUCTION OF THE DEVICE. THERE WERE BIOLOGICAL CONTAMINANTS ON THE OUTSIDE DIAMETER OF THE OUTER HUB AND OUTER TUBE, AND THE INSIDE DIAMETER OF THE DISTAL TIP. THE PROXIMAL OUTSIDE DIAMETER OF THE OUTER HUB (LOCKING AREA) SHALL BE 0.340 +0.003/-0.001 INCHES AND THE ACTUAL MEASUREMENTS WERE BETWEEN 0.339 AND 0.341 INCHES WHICH WAS IN SPECIFICATION. FUNCTIONALLY, THE INNER ASSEMBLY SPUN FREELY BY HAND WITH NO BINDING. THE BLADE FIT SECURELY INTO A HANDPIECE, BUT WHILE OSCILLATING AT 1500 RPM, THE ENTIRE BLADE BEGAN TO UNINTENTIONALLY ROTATE. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED NO OTHER COMPLAINTS ABOUT THIS LOT NUMBER. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT DURING FESS PROCEDURE, THE BLADE SEATED APPROPRIATELY BUT WHEN THE DOCTOR HIT THE FOOT PEDAL IT WOBBLED. THEY STOPPED USING THE BLADE AND REPLACED IT WITH ANOTHER TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882916 0224602731 00721902755057

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male