BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 14566903 · Received June 1, 2022

    Report

    Report Number
    1045254-2022-00295
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 25, 2022
    Report Date
    July 4, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00885074080642
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: VISUALLY, THERE WAS BIOLOGICAL CONTAMINANT COATING MOST OF THE DEVICE. THE SPIRAL WRAP OF THE MIDDLE TUBE WAS EXPANDED APPROXIMATELY 0.10 INCHES FROM THE DISTAL END OF THE OUTER SHEATH WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WAS NO DAMAGE TO THE DISTAL TIP. THERE WERE NO LOOSE COMPONENTS. FUNCTIONALLY, THERE WAS BINDING WHILE ROTATING THE INNER ASSEMBLY BY HAND, BUT THE MIDDLE ASSEMBLY COULD NOT ROTATE AT ALL. CONSOLE FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE AFOREMENTIONED DEFECTS. THERE WAS NO ALLEGATION OF A DEFECT PRIOR TO USE. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED THREE SIMILAR COMPLAINTS ABOUT THIS LOT NUMBER. CONCLUSION: IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT (DUE TO PHYSICAL DAMAGE). EARLIER SUBMITTED CODE B21, C21 AND D16 ARE NO LONGER APPLICABLE.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.

    Description of Event or Problem · 0

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE DID NOT WORK CORRECTLY DURING SINUS SURGERY AND HAD THE STAFF SAVE IT. HE PROCEEDED WITH A DIFFERENT BLADE, BUT THE STAFF DID NOT KNOW THE DETAILS OF WHAT MALFUNCTIONED. ON ADDITIONAL INFORMATION, IT INDICATED THE INTERIOR OF THE BLADE BECAME DISCONNECTED. THERE WAS NO CASE DELAY NO PATIENT IMPACT. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION RECEIVED AND IT CLARIFIED THAT CONNECTION ISSUE WAS NOT AN ELECTRICAL CONNECTION ISSUE, IT WAS LIKE THE BLADES 2 PIECES CAME APART AND WOULD NOT OSCILLATE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600824 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884016HR 0217636379 00885074080642

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male