BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCOPE 4 BRONCHO SLIM

    MDR report key: 12046325 · Received June 22, 2021

    Report

    Report Number
    1220828-2020-00004
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    April 28, 2020
    Report Date
    May 19, 2020
    Manufacturer
    AMBU A/S
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE CAN BE SIMULATE BY SIMULATION TEST. THE TEST RESULTS SHOWED WHEN BENDING SECTION WAS NOT IN STRAIGHT CONDITION, THE DISTAL END CAN BE PULLED INTO DOUBLE LUMEN TUBE AND STUCK AT THE INLET OF TUBE. FURTHER PULLING THE BRONCHOSCOPE WITH EXCESSIVE FORCE CAN LEAD TO THE RUPTURE OF DISTAL TIP. ACCORDING TO PRODUCT IFU, THE DISTAL TIP SHOULD BE SET IN A NEUTRAL OR NON-DEFLECTED POSITION WHEN WITHDRAW AND EXCESSIVE FORCE SHOULD BE AVOIDED WHEN USING THE PRODUCT: DO NOT USE EXCESSIVE FORCE WHEN ADVANCING, OPERATING OR WITHDRAWING THE ASCOPE 4 BRONCHO. WHEN WITHDRAWING THE ENDOSCOPE, THE DISTAL TIP MUST BE IN NEUTRAL AND NON-DEFLECTED POSITION. DO NOT OPERATE THE BENDING LEVER, AS THIS MAY RESULT IN INJURY TO THE PATIENT AND/OR DAMAGE TO THE ASCOPE 4 BRONCHO. THIS MDR IS RESUBMITTED AGAIN AS IT WAS IDENTIFIED THAT ORIGINAL SUBMISSION HAD NOT BEEN SUCCESSFULLY LOADED INTO THE FDA DATABASE DUE TO WRONG FILE FORMAT. THE INITIAL MDR OF THIS INCIDENT WAS SUBMITTED TO THE FDA WITHIN THE ORIGINAL REPORTING DEADLINE. THIS SUBMISSION REPRESENTS A RELOAD OF DATA TO ENSURE CORRECT UPLOAD TO THE FDA DATABASE.

    Description of Event or Problem · 1

    THE END OF ENDOSCOPE HAS BROKEN OFF INSIDE A 39 FR. DOUBLE LUMEN TUBE. THE BROKEN END WAS RETRIEVED. PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942509 ASCOPE 4 BRONCHO SLIM FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE, EOQ AMBU A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention