BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVASIGHT 2 DLT KIT 39 FR - LEFT

    MDR report key: 20853676 · Received December 5, 2024

    Report

    Report Number
    1220828-2024-00024
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 5, 2024
    Manufacturer
    AMBU A/S
    Product Code
    CBI
    UDI-DI
    05707480145768
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE VERIFIED THE REPORTED FAILURE OF THE PRODUCT'S TIP BEING BENT, FROM THE RETENTION SAMPLE OF THE SAME MANUFACTURING LOT. ANGLE MEASUREMENT FROM END TO TIP OF ENDOTRACHEAL BEVEL WAS PERFORMED, IN ORDER TO EVALUATE IF THE BENDING IS WITHIN SPECIFICATIONS (15°-53°). THE ANGLE OF THE RETENTION SAMPLE WAS 60°, THUS OUTSIDE OF SPECIFICATIONS. CORRECTIVE ACTION HAD BEEN INITIATED TO INVESTIGATE THIS ISSUE AND THE PRELIMINARY INVESTIGATION SHOWED THAT THE BENDING WAS CAUSED BY MISHANDLING BY MANUFACTURING PERSONNEL, IN WHICH ADDITIONAL BENDING OF ENDOBRONCHIAL TIP OCCURRED AFTER STYLET INSERTION PROCESS. THERE IS AN ONGOING RECALL 'AMBU2024FA00001' WHICH WAS INITIATED DUE TO HYPERANGULATION OF THE DISTAL TIP. THE LOT NUMBER OF THE AFFECTED PRODUCT INVOLVED IN THIS INCIDENT CORRESPONDS TO THE LOT NUMBERS AFFECTED BY THE RECALL.

    Description of Event or Problem · 0

    THE INCIDENT LEADING TO TONSIL INJURIES OCCURRED IN TWO SEPARATE PROCEDURES (THE SECOND INCIDENT IS COVERED BY 1220828-2024-00025). A CRNA WAS TRYING TO INTUBATE WITH THE VIVASIGHT 2 DLT PRODUCT AND THEY HAD TO ADJUST THE DISTANCE OF TIP OF THE TUBE PAST THE VOCAL CORDS. THE CURVE AT THE END OF THE BRONCHIAL LUMEN WAS MORE ANGULATED THAN A TYPICAL ROBERT-SHAW DOUBLE LUMEN ENDOTRACHEAL TUBE, AND GOT MORE EASILY CAUGHT ON THE TRACHEAL RINGS. ONE COULD EITHER ADVANCE THE BRONCHIAL CUFF FURTHER PAST THE VOCAL CORDS WITH THE STYLET, OR IF THE STYLET WAS REMOVED AFTER THE TIP WAS IN THE TRACHEA, ONE COULD TURN THE TUBE 120-180 DEGREES LEFTWARD WHILE ADVANCING AND THEN RETURN IT TO 90 DEGREES ONCE PAST THE RING THAT THE TIP GOT HUNG UP ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078840 VIVASIGHT 2 DLT KIT 39 FR - LEFT VIVASIGHT 2 DLT KIT 39 FR - LEFT CBI AMBU A/S 412391000 1000989835 05707480145768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other