BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS 3724312 EAR 3MM BLADES

    MDR report key: 2992856 · Received March 7, 2013

    Report

    Report Number
    1045254-2013-00227
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    JZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AS REPORTED, THE SURGEON WAS IN THE MIDDLE OF A CASE AND THE TIP BROKE OFF THE SCISSOR. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96959 SCISSORS 3724312 EAR 3MM BLADES SCISSORS, EAR JZB MEDTRONIC XOMED, INC. 3724312 201206MF3

    Patients

    Seq Age Sex Outcome Treatment
    1