BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - VISAO®

    MDR report key: 7076803 · Received December 1, 2017

    Report

    Report Number
    1045254-2017-00440
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 8, 2017
    Report Date
    March 1, 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

    THE DEVICE WAS RETURNED FOR EVALUATION AND SERVICED. 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. AS A RESULT OF INITIAL CHECKOUT AT THE ANALYSIS CENTER, IT WAS NOTICED THAT THE TIP OF THE BEARING SLIGHTLY WORN. THERE WAS NO OTHER ISSUE NOTICED. SERVICING OF THE DEVICE FOUND THE BALL, O'RINGS,AND BEARING DETERIORATED, THEY WERE DIRTY AND RUSTY. PARTS WERE REPLACED. THE UNIT WAS CLEANED AND TESTED TO MANUFACTURERS SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: 3334625 - GUARD 3334625 VISAO BUR W/O IRRIGATION, 510K: K983224, PRODUCT CODE: ERL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED DESCRIBED THAT THE FOREIGN MATERIAL WAS LIKE ASH"; THE SUBSTANCE WAS NOT "SMALL METAL PIECES" AS INITIALLY REPORTED. SALINE AND SUCTION WERE USED FOR RETRIEVAL AND ALL OF THE SUBSTANCE WAS SUCCESSFULLY RETRIEVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TYMPANOPLASTY SURGERY, SMALL METAL PIECES (DEBRIS/FRAGMENTS) FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855528 XPS® HANDPIECE - VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800 NI

    Patients

    Seq Age Sex Outcome Treatment
    1