BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ WEAPON

    MDR report key: 212343 · Received February 23, 1999

    Report

    Report Number
    212343
    Event Type
    Malfunction
    Date Received
    February 23, 1999
    Date of Event
    December 15, 1998
    Report Date
    February 8, 1999
    Manufacturer
    KARL STORZ
    Product Code
    JYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR ON 02/23/99: THE ENCLOSED MEDWATCH WAS FORWARDED TO BAUSCH & LOMB SURGICAL, INC. FROM KARL STORZ ENDOSCOPY. IT IS NOT KARL STORZ' DEVICE. THEREFORE THE DEVICE WAS FORWARDED TO FDA.

    Description of Event or Problem · 1

    A 37 YEAR OLD FEMALE PATIENT WITH CHRONIC OTITIS MEDIA WAS UNDERGOING RIGHT TYMPANOMASTOIDECTOMY PROCEDURE WHEN THE DISK PORTION ON THE SMALL WEAPON BROKE OFF WHILE THE PHYSICIAN WAS USING THE INSTRUMENT IN THE PATIENT'S MASTOID. THE PHYSICIAN WAS ABLE TO REMOVE THE DISK FROM PATIENT AND HANDED THE INSTRUMENT OFF THE FIELD. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ WEAPON EAR INSTRUMENT JYG KARL STORZ * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other