MAUDE Adverse Event Report: AMBU A/S VIVASIGHT 2 DLT KIT 41 FR - LEFT

Model Number	KIT 41 FR - LEFT
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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 9610691-2026-00005.
Additional Manufacturer Narrative
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 instructionf 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.

• Brand Name: VIVASIGHT 2 DLT KIT 41 FR - LEFT
• Common Device Name: VIVASIGHT 2 DLT
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69b lintang bayan lepas 6; phase iv; penang, 11900 ; MY 11900
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 24387190
• Report Number: 9610691-2026-00004
• Device Sequence Number: 21488268
• Product Code: CBI
• UDI-Device Identifier: 05707480145799
• UDI-Public: 05707480145799
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KIT 41 FR - LEFT
• Device Catalogue Number: 412411000
• Device Lot Number: 1001168835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown