BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS SYSTEM NAVIGATED BLADE

    MDR report key: 11854259 · Received May 20, 2021

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    Report

    Report Number
    9612501-2021-00781
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    September 14, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    EQJ
    UDI-DI
    00763000034023
    PMA / PMN Number
    K130608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND THAT BOTH INNER AND MIDDLE ASSEMBLIES WOULD ROTATE FREELY. THE BLADE WAS PLACED INTO A HANDPIECE WITH NO ISSUES WITH FITMENT. THE SETTINGS WERE PLACED ON 7,500 RPM IN OSCILLATING MODE. A CONCENTRICITY GAUGE WAS USED ON THE INNER SHAFT, AND THE HUB WAS ECCENTRIC TO THE INNER SHAFT. H6: FDM B17, FDR C20 AND FDC D14 NO LONGER APPLY. THIS IS SAME EVENT AS REGULATORY REPORT #: 9612501-2021-00766. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT BLADE WAS VIBRATING MORE THAN NORMAL DURING ENDOSCOPIC SINUS SURGERY. THE SURGICAL TECH THEN RE-SEATED THE BLADE BUT STILL HAD VIBRATING ISSUE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE BLADE VIBRATED BEFORE AND DURING USE ON PATIENT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION FROM REP REPORTED THAT THERE WERE TWO BLADES OPENED WITH THE SAME ISSUE IN WHICH BOTH VIBRATED BEFORE AND DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752662 XPS SYSTEM NAVIGATED BLADE BUR, EAR, NOSE AND THROAT EQJ COVIDIEN LLC 1884380EM 0221619316 00763000034023

    Patients

    Seq Age Sex Outcome Treatment
    1