BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOMED® INSTRUMENTS

    MDR report key: 4576287 · Received March 6, 2015

    Report

    Report Number
    1045254-2015-00066
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    January 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    JYT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE PRODUCT ANALYSIS INDICATES THAT THE TIP WAS BROKEN OFF. THE FRAGMENT WAS ALSO RETURNED. THERE WAS NO EVIDENCE OF ANY MATERIAL DEFECTS THAT WOULD HAVE RESULTED IN THE BREAK. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS MISUSE/USER ERROR. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FINE TIP OF THE PRODUCT BROKE OFF INTO THE PATIENT. SHE STATED THE FRAGMENT WAS PICKED UP ¿PRETTY EASILY¿ AND REMOVED FROM THE PATIENT. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159921 XOMED® INSTRUMENTS PICK, MICROSURGICAL EAR JYT MEDTRONIC XOMED, INC. 3722071 NI

    Patients

    Seq Age Sex Outcome Treatment
    1