BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS BUR

    MDR report key: 11806151 · Received May 11, 2021

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    Report

    Report Number
    1045254-2021-00237
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 9, 2021
    Report Date
    September 22, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS FOUND VISUALLY, THE INNER SHAFT TOWARD THE TIP WAS BENT AND WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP WAS HEAVILY COMPACTED WITH BIOLOGICAL CONTAMINANT, WHICH WOULD LIKELY REQUIRE THE USER TO APPLY EXTRA PRESSURE TO MAINTAIN PERFORMANCE. FUNCTIONALLY, THE BUR WOULD NOT SPIN FREELY BY HAND. WHEN PLACED INTO A HANDPIECE, THE DEVICE FIT SECURELY BUT DID NOT OSCILLATE SMOOTHLY; THE SHAFT VIBRATED WHILE RUNNING AT 3000 RPM. THERE WAS NO ALLEGATION OF DIFFICULTIES LOADING THE BUR OR DAMAGE PRIOR TO USE. THE INFORMATION MOST LIKELY INDICATES EXCESSIVE USAGE AND PRESSURE LED TO UNWARRANTED FRICTION BETWEEN SUBASSEMBLIES AND EVENTUAL BENDING/DEFORMATION OF THE SHAFT. H6: FDC D14; FDR C20; FDM B17 NO LONGER APPLICABLE. 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 HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT WHEN THE DOCTOR USED THE BUR FOR ABOUT HALF AN HOUR, THE FRONT OF THE BUR SUDDENLY BEGAN TO SHAKE DURING THE FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) PROCEDURE. THE DOCTOR TRIED TO REINSTALL THE BUR BUT IT WAS USELESS. FINALLY, THE DOCTOR DECIDED TO REPLACE IT WITH A NEW ONE TO COMPLETE THE OPERATION. THE PRODUCT HAD CONTACT WITH THE PATIENT AND THERE WAS A DELAY OF ABOUT THREE MINUTES. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705118 XPS BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883672HS 0219742623

    Patients

    Seq Age Sex Outcome Treatment
    1