BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - VISAO®

    MDR report key: 7075474 · Received December 1, 2017

    Report

    Report Number
    1045254-2017-00437
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 4, 2018
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 3334625 - GUARD 3334625 VISAO BUR W/O IRRIGATION, LOT NUMBER UNKNOWN 510K: K983224. PRODUCT EVALUATION: EVALUATION RESULTS FOR THE HANDPIECE ALSO REPORTED THAT "THE BEARINGS OF THE TOP ARE BLACK"; DETERIORATION OF BEARINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE ANALYSIS INDICATED THAT THE UNIT WAS DISASSEMBLED AND COULD NOT FIND ANY PARTS THAT WERE BROKEN OR HAD METAL PIECES COMING APART. COULD NOT VERIFY CUSTOMERS ISSUE. FOR NORMAL REPAIR, REPLACED LOCKING NUT DUE TO MISSING ALIGNMENT DOT. UNIT WAS CLEANED AND TESTED TO MANUFACTURERS SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: "ACCORDING TO THE UPDATED REPORT FROM SALES REP, THE FOREIGN MATERIALS FELL OFF WERE SUBSTANCES LIKE ASH", NOT "SMALL METAL PIECES" AS INITIALLY REPORTED. IT WAS ALSO CONFIRMED THAT A BUR GUARD WAS IN USE WHEN THIS OCCURRED; THE DEBRIS MAY HAVE BEEN FALLING FROM THE BUR GUARD AND NOT THE HANDPIECE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TYMPANOPLASTY SURGERY, SMALL METAL PIECES (DEBRIS/FRAGMENTS) FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED BY USING SALINE AND SUCTION AND DID NOT REQUIRE ADDITIONAL EQUIPMENT OR AN ADDITIONAL PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855117 XPS® HANDPIECE - VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800 37091800

    Patients

    Seq Age Sex Outcome Treatment
    1