MAUDE Adverse Event Report: AMBU A/S VIVASIGHT¿ 2 DLT KIT 37 FR - LEFT; VIVASIGHT 2 DLT KIT 37 FR - LEFT

Catalog Number	412371000
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were unable to verify the reported failure (the suction catheters do not pass down from the sample returned as ambu suction catheter able to pass through the tube.The possible cause of reported failure could be due to suction catheter used was incompatible with the dlt used during the procedure, which lead to difficulty in advancing the catheter through the dlt.Ambu production and qc performs 100% tube integrity inspection on each of the vivasight 2 and the vivasight 2 was verified in good condition prior to shipment.Production, technical team and quality control have been made aware of this feedback via quality alert.
Event or Problem Description
Couldn't pass suction catheter down the tube.Catheter bending back on itself when hitting the inner lumen of dlt.Applied lubricant to catheter but it made no difference.Additional information received: · procedure started ~20 minutes late because the suction catheter couldn't be passed down the lumen.Had to open x3 different catheters to remove secretions (ambu comment: the first issue/complint for the reported event).· procedure had to be stopped multiple times as the lung was not deflating.Surgeons utilized their tools to squeeze the lung but this would only stay flat for a short amount of time.To circumnavigate this, the consultant would turn off ventilation completely, effectively making the patient apneic.She would turn it back on after a minute and continue fluctuating on bilateral and one lung ventilation (ambu comment: the second issue/complaint for the reported event.A non-deflating lung is most commonly caused by malposition of the tube or by patient related factors).· the procedure had to be stopped, with the dlt removed and a standard ett replacing it.They then wanted to send the patient off for a scan, before determining if they needed to do an open chest procedure (please note i do not know if this was directly because of the dlt or if patient factors were at play here.This patient needed the lobectomy to treat her cancer, and the consultant noted she was naturally hypoxic).

• Brand Name: VIVASIGHT¿ 2 DLT KIT 37 FR - LEFT
• Common Device Name: VIVASIGHT 2 DLT KIT 37 FR - LEFT
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69-b, lintang; bayan lepas 6, phase iv; penang, mys 1900, ; MY 1900,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 24453460
• Report Number: 9610691-2026-00006
• Device Sequence Number: 13253945
• Product Code: CBI
• UDI-Device Identifier: 05707480145737
• UDI-Public: 05707480145737
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 412371000
• Device Lot Number: 1001200730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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