BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS SYSTEM NAVIGATED BLADE

    MDR report key: 11678284 · Received April 16, 2021

    Report

    Report Number
    9612501-2021-00622
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 19, 2021
    Report Date
    June 11, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    HAW
    PMA / PMN Number
    K130608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS FOUND THAT VISUALLY, THE END OF THE SHAFT WITH THE HUB HAD BEEN PUSHED TIGHT AGAINST THE OUTER TUBE AREA INDICATING SPIRAL WRAP DAMAGE. IN ADDITION, THE TIP BROKE OFF AND THE MIDDLE ASSEMBLY TIP HAD BEEN PUSHED OUT OF THE OUTER TUBE SUPPORT AREA INDICATING SPIRAL WRAP DAMAGE. THE SHRINK TUBING MAY HAVE BEEN OUT OF TOLERANCE CAUSING AN INTERFERENCE FIT. THE INFORMATION MOST LIKELY INDICATES AN INTERFERENCE ISSUE OF THE DIAMETERS DURING MANUFACTURING, ULTIMATELY RESULTING IN THE REPORTED EVENT. THE INNER BLADE WAS REMOVED AND SPUN ON A FLAT RAISED SURFACE. THE HUB APPEARED TO BE CONCENTRIC. USING A CONCENTRICITY GAGE THE HUB WAS FOUND TO BE +/- 0.002¿. H6: THE FDM B17, FDR C20 AND FDC D14 NO LONGER APPLIES. 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 REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE HCP WAS PERFORMING A STANDARD FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE AND WHEN SHAVING THE SINUSES WITH THE BLADE, THE INNER PIECE BROKE AND BECAME LOOSE FROM THE OUTER PIECE. THE HCP OPENED A NEW BLADE AND CONTINUED THE PROCEDURE. THERE WAS NO PATIENT INJURY. ON FOLLOW UP, IT WAS REPORTED THAT THERE WERE FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BROKEN DEVICE. THE FRAGMENTS WERE IN THE PATIENT. AN X-RAY WAS DONE ON THE PATIENT DURING THE PROCEDURE TO SEE WHERE THE METAL PIECES WERE, AND THEN CAREFULLY REMOVED BY INSTRUMENTS FROM THE PATIENT. THERE WERE NO ADDITIONAL ACTIONS TAKEN TO PREVENT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574963 XPS SYSTEM NAVIGATED BLADE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW COVIDIEN LLC 1884006EM 0220804521

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other