BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESI STANDAD BRONCHOSCOPE FORCEP

    MDR report key: 3777 · Received February 1, 1993

    Report

    Report Number
    3777
    Event Type
    Injury
    Date Received
    February 1, 1993
    Report Date
    February 1, 1993
    Manufacturer
    ENDO-SCIENTIFIC
    Product Code
    JEK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING BIOSPY, PORTION OF BRONCHOSCOPY-FORCEP SEPERATED FROM CASING AND ADVANCED 1-1/2-2 INCHES INTO LUNG CAUSING PNEUMOTHORAXINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESI STANDAD BRONCHOSCOPE FORCEP JEK ENDO-SCIENTIFIC 313 K 120CM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention