BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVASIGHT 2 DLT KIT 41 FR - LEFT

    MDR report key: 24392621 · Received February 19, 2026

    Report

    Report Number
    1220828-2026-00004
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    January 19, 2026
    Report Date
    February 19, 2026
    Manufacturer
    AMBU A/S
    Product Code
    CBI
    UDI-DI
    05707480145799
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE WERE UNABLE TO VERIFY THE REPORTED FAILURE (CUFF WOULD NATURALLY DEFLATE) AS NO SAMPLE NOR ANY PHOTO/VIDEO WAS RETURNED FOR INVESTIGATION. NOTE THAT SINCE NO SERIOUS INJURY HAS BEEN CONFIRMED WE FILE THIS REPORT AS A MALFUNCTION UNDER H1 FIELD. THE INCOMING INSPECTION RECORD FOR THE RAW TUBE WAS REVIEWED SHOWING THAT THE TRACHEAL CUFF BURST PRESSURE HAVE MET THE SPECIFICATION. FUNCTIONALITY INSPECTION IS DONE ON 100% OF VIVASIGHT 2 PRODUCTS VERIFYING THAT THE PRODUCTS ARE IN GOOD CONDITION PRIOR TO SHIPMENT. THE POSSIBLE CAUSE FOR THE REPORTED FAILURE COULD BE THAT TRACHEAL CUFF WAS DAMAGED DURING INTUBATION UPON CONTACT WITH PATIENT'S TEETH, RESULTING IN THE CUFF NOT BEING ABLE TO BE INFLATED. HOWEVER, AS THERE WAS NO SAMPLE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULDN'T BE DETERMINED. ACCORDING TO THE INSTRUCTION FOR USE, 'CARE MUST BE TAKEN TO AVOID DAMAGING THE CUFF DURING INTUBATION AS TEETH OR ANY INTUBATION AID WITH SHARP SURFACES CAN DAMAGE THE CUFF.' PRODUCTION, TECHNICAL TEAM AND QUALITY CONTROL HAVE BEEN MADE AWARE OF THIS INCIDENT VIA QUALITY ALERT. WE WILL CONTINUE MONITORING THE MARKET FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 0

    DOCTOR ATTEMPTED STANDARD THORACIC PROCEDURE - INTUBATION OF A PATIENT USING VIVASIGHT 2 DLT. FIRST, THEY USED A 41FR AND THEN DOWNSIZED TO A 39FR. BOTH DLTS HAD THE CUFF BURST. CONSULTANT INFLATED THE CUFF WITH 2-3ML OF AIR AND THE CUFF WOULD NATURALLY DEFLATE. ADDITIONAL INFORMATION FROM THE HOSPITAL WAS PROVIDED BY THE DOCTOR: 'INTERMITTENTLY WE RUN INTO AN ISSUE IN WHICH DESPITE THE OPERATIVE LUNG BEING ISOLATED IT IS NOT DEFLATING WHEN OPENED TO AIR. CONDITION PERSISTS EVEN WITH APPLICATION OF DIRECT SUCTION. AIRWAY MANAGED DESPITE COMPROMISES TO THE SURGERY. MAY HAVE RESULTED IN THE NEED FOR LARGER INCISIONS AND EVEN UNNECESSARY THORACOTOMIES. TUBE CHANGED TO SHILEY BRONCOCATH OR BRONCHOSCOPE USED TO DOUBLE CHECK PLACEMENT DESPITE TUBE SEEMINGLY BEING WELL PLACED ACCORDING TO THE INBUILT CAMERA.'' IT IS NOT INDICATED THAT THE PATIENT EXPERIENCED ASSOCIATED HARM OF HYPOXIA, SINCE PATIENT'S AIRWAY WAS MANAGED. HOWEVER, DUE TO LACK OF INFORMATION ON THE COMPROMISES TO THE SURGERY, THE INCIDENT IS BEING REPORTED. NOTE THAT TWO REPORTS ARE BEING SUBMITTED DUE TO THE INVOLVEMENT OF TWO DEVICES. THE MANUFACTURER REFERENCE NUMBER OF THE SECOND REPORT IS 1220828-2026-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449786 VIVASIGHT 2 DLT KIT 41 FR - LEFT VIVASIGHT 2 DLT CBI AMBU A/S KIT 41 FR - LEFT 1001168835 05707480145799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other