BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TONSIL WIRE (SNARE)

    MDR report key: 8202 · Received August 11, 1993

    Report

    Report Number
    8202
    Event Type
    Malfunction
    Date Received
    August 11, 1993
    Date of Event
    June 29, 1993
    Report Date
    July 7, 1993
    Manufacturer
    STORZ
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    END OF THE TONSIL WIRE BROKEN WHILE REMOVING THE RIGHT TONSIL. WIRE PIECE COULD NOT BE FOUND IN THE PATIENT'S THROAT, NO CLINICAL PROBLEMS NOTED WHILE PATIENT WAS IN OR OR PACU.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TONSIL WIRE (SNARE) KBZ STORZ

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other