BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 MM MONOPOLAR SPATULA TIP ACCESSORY

    MDR report key: 2447516 · Received January 24, 2012

    Report

    Report Number
    8043817-2012-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    November 21, 2011
    Report Date
    January 23, 2012
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT AND PATIENT INFORMATION HAS BEEN REQUESTED. DEVICE HAS BEEN REQUESTED FOR EVALUATION.

    Description of Event or Problem · 1

    (B)(6), WHERE THE 5 MM SPATULA TIP (B)(4) COULD NOT BE REAPPLIED BECAUSE OF WELD CASING BROKE AND WAS STILL LODGED IN THE INSTRUMENT (B)(4). NO FRAGMENT FELL INTO PATIENT. NOTE: SCRUB TECH WAS UNABLE TO APPLY 5MM SPATULA TIP TO THE 5MM MONOPOLAR CAUTERY INSTRUMENT. A NEW INSTRUMENT HAD TO BE OPENED TO CONTINUE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 MM MONOPOLAR SPATULA TIP ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY MICROTEK MEDICAL, INC. 400160-02 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other