BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSS EAR CUP FORCEPS

    MDR report key: 4722176 · Received March 19, 2015

    Report

    Report Number
    4722176
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    January 2, 2015
    Report Date
    March 19, 2015
    Manufacturer
    BOSS INSTRUMENTS, LTD.
    Product Code
    KAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING AN OPERATIVE PROCEDURE, A MICROPITUITARY BEING USED BY DOCTOR BROKE. THE METAL PIECE THAT BROKE OFF WAS RETRIEVED. THE INSTRUMENT WAS REMOVED FROM THE STERILE FIELD AND GIVEN TO MATERIALS COORD. AN X-RAY WAS TAKEN AND READ AS NEGATIVE FOR METAL. DOCTOR AWARE OF X-RAY RESULTS. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187113 BOSS EAR CUP FORCEPS FORCEPS, ENT KAE BOSS INSTRUMENTS, LTD. 90-2181 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR