BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 7042850 · Received November 17, 2017

    Report

    Report Number
    1045254-2017-00417
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 20, 2017
    Report Date
    February 19, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION / ANALYSIS. THERE WAS ONE OPENED SAMPLE OF PART NUMBER 1884006 FROM LOT NUMBER HGIQVYF. THERE WAS A RESIDUE CONSISTENT WITH BIOLOGICAL CONTAMINANTS ON THE DEVICE. THE INNER SHAFT BROKE 0.61¿ FROM THE DISTAL FACE OF THE INNER HUB WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. THE BREAK POINT CORRESPONDS TO A BEND IN THE OUTER TUBE DISTAL TO THE FRONT HUB. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DEFORMATION OF THE LOCKING AREA ON THE FRONT HUB AND STRIATIONS AROUND THE OUTSIDE DIAMETER OF THE BREAK POINT INDICATING METAL ON METAL CONTACT. THE INFORMATION INDICATES EXCESS PRESSURE WAS APPLIED DURING USE WHICH CAUSED THE DEFORMATION OF THE LOCKING AREA AND THE BEND IN THE OUTER TUBE; WHICH THEN CAUSED THE INNER SHAFT AND OUTER TUBE TO RUB TOGETHER UNTIL THE INNER SHAFT BROKE. THERE WAS NO INDICATION OF DEVICE FRAGMENTS AND THE BREAKAGE WOULD HAVE BEEN CONTAINED BY THE OUTER TUBE AND THE HAND-PIECE. THERE WAS AN OUT OF SPECIFICATION CONDITION IDENTIFIED AS IT RELATES TO THE COMPLAINT. THE MOST LIKELY UNDERLYING CAUSE IS CONSISTENT WITH, MISUSE / USE ERROR. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE ISSUE TOOK PLACE OUTSIDE OF THE PATIENT'S BODY. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE "HEAD" (TIP) OF THE RAD 40 BLADE WAS BROKEN DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822086 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884006 HGIQVYF

    Patients

    Seq Age Sex Outcome Treatment
    1