BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCOPE 4 BRONCHO LARGE

    MDR report key: 11940894 · Received June 4, 2021

    Report

    Report Number
    1220828-2020-00009
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    September 16, 2020
    Report Date
    October 15, 2020
    Manufacturer
    AMBU A/S
    Product Code
    EOQ
    UDI-DI
    05707480135530
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. AMBU WAS ABLE TO VERIFY THE REPORTED FAILURE (CONTROL LEVER HAD BROKEN LOOSE). AMBU INVESTIGATED THE DEFECTIVE SAMPLE AND FOUND THAT THE CONTROL LEVER WAS LOOSE DUE TO A DETACHED STEERING WIRE ON THE INSIDE OF THE ENDOSCOPE. WITH THE WIRE DETACHED, THE ENDOSCOPE WON'T FUNCTION AS INTENDED AND WON'T BE ABLE TO BEND THE TIP. INVESTIGATION OF THE DEFECTIVE SAMPLE AND THE RETENTION SAMPLE FROM THE SAME LOT SUGGEST THAT THE WIRE HAS BEEN DETACHED DUE TO EXCESSIVE FORCE ON THE LEVER. THE WIRE WAS SHOWN TO HAVE THE SPECIFIED DIAMETER AND THE CRIMPING WAS OBSERVED TO BE FULLY COMPRESSED ON THE DEFECTIVE DEVICE. PULL STRENGTH TEST WERE PERFORMED ON BOTH THE DEFECTIVE DEVICE AND THE RETENTION SAMPLE AND BOTH DEVICES PASSED THE TEST. AS A CONCLUSION, AMBU HAS RULED OUT DEFECTIVE STEERING WIRE AND IMPROPER CRIMPING AS CAUSE OF THE DEFECT. THE COMPLAINT STATES THAT THE DEFECT WAS ONLY DETECTED AFTER THE DEVICE HAD BEEN USED. AS A PRECHECK IS PRESCRIBED, IT IS EVALUATED THAT THE FAULT OCCURED AS A RESULT OF THE USER APPLYING EXCESSIVE FORCE DUE TO HAVING DIFFICULTIES MANEUVERING THE ENDOSCOPE WITHIN A SMALLER SPACE (EG. THE ET TUBE). THIS IS CHARACTERISED AS ROUGH HANDLING IN THE PRODUCT RISK EVALUATION. IT IS EVALUATED IN THE PRODUCT RISK EVALUATION THAT BREAKAGE OF THE ASCOPE 4 BRONCHO DUE TO ROUGH HANDLING BY THE USER WILL NOT POSE A SERIOUS RISK OF HARM TO THE PATIENT OR USER. THE USER IS ADVISED TO HAVE A SUITABLE BACK UP READY IN CASE OF A DEFECTIVE DEVICE. IN THIS CASE TWO CONSECUTIVE DEVICES BROKE DUE TO ROUGH HANDLING, AND THAT IS WHAT LEAD TO THE HAZARDOUS SITUATION AND DESATURATION OF THE PATIENT.

    Description of Event or Problem · 1

    DURING A FIBERSCOPY IN THE ICU THE CONTROL LEVER OF AN ASCOPE 4 BRONCHO BROKE. THE HEALTHCARE PROFESSIONALS IMMEDIATELY TRIED ANOTHER ASCOPE4 BRONCHO FROM THE SAME BATCH, BUT THE CONTROL LEVER OF THAT SCOPE ALSO BROKE. DUE TO THE PROLONGED PROCEDURE, THE PATIENT DESATURATED. THE ENDOSCOPY WSA THEN PERFORMED WITH A FUNCTIONAL ENDOSCOPE. PATIENT SATURATION LEVEL RETURNED TO NORMAL. NO LONG TERM SERIOUS HEALTH DETERIORATION FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833297 ASCOPE 4 BRONCHO LARGE FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE EOQ AMBU A/S 478001000 1000397858 05707480135530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention