BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER ANGLED COTTLE SPRING SCISSOR

    MDR report key: 3831952 · Received May 20, 2014

    Report

    Report Number
    3831952
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    KBD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING ENDOSCOPIC FRONTAL SINUSOTOMY. DURING THE SURGICAL PROCEDURE, THE END OF THE ANGLED COTTLE SPRING SCISSOR BROKE OFF INTO THE PATIENT'S NOSE. THE BROKEN PIECE WAS RETRIEVED BY THE SURGEON AND INSPECTED TO ENSURE ALL OF THE INSTRUMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298870 V. MUELLER ANGLED COTTLE SPRING SCISSOR SCISSORS, NASAL KBD CAREFUSION 2200, INC. * XTA1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR