BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ

    MDR report key: 292306 · Received August 25, 2000

    Report

    Report Number
    292306
    Event Type
    Malfunction
    Date Received
    August 25, 2000
    Date of Event
    August 23, 2000
    Report Date
    August 24, 2000
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    JYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A RIGHT TYMPANO-MASTOIDECTOMY. DURING PROCEDURE TIP OF MICRO EAR CURETTE INSTRUMENT BROKE OFF (2MM). THE EAR WAS EXAMINED & IRRIGATED UNDER MICROSCOPY & NO FOREIGN BODY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ MICRO EAR CURETTE JYG BAUSCH & LOMB SURGICAL 4C *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other