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

Catalog Number	412371000
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ambu were unable to verify the reported failure (bending angles at the distal end of unused visi 2 dlts are different) as no sample was returned for investigation and no lot number available.The possible cause for reported failure could be due to operator mishandling in which additional bending of endobronchial tip occurred after stylet insertion process, resulting in bending angles are different.Unfortunately, ambu has not been able to get in contact with the reporter, which previously informed to have more information.Ambu will continue to get in contact with the initial reporter for more informaition.Corrective action has previously been implemented which enhance the bending inspection during assembly.Ambu production and quality control perform 100% inspection on each of the vivasight2 and it was verified in good condition prior shipment.Production, technical team and quality control have been made aware of this feedback via quality alert.
Event or Problem Description
The doctor pointed out to us that the bending angles at the distal end of unused visi 2 dlts are different.We compared different lot and item numbers.All items have been discarded by the hospital, no sample available.The doctor has furthermore, informed that during several intubations, there were difficulties advancing the tube after passing the vocal cords.The first photo shows the packaging with the label of one of the "problematic tubes." the other two photos show the (significant) difference in the bronchial curvature compared to a conventional competitor product (with which there are indeed no problems during placement).Comment from ambu: unfortunately, no photos or exact information on item numbers and lot numbers were provided by the doctor.Ambu has despite several follow-up attempts not been able to get in contact with him.Ambu have created the mdr report on vivasigth dlt kit size 37.
Additional Manufacturer Narrative
Initial mdr report 01/06/2026: ambu were unable to verify the reported failure (bending angles at the distal end of unused visi 2 dlts are different) as no sample was returned for investigation and no lot number available.The possible cause for reported failure could be due to operator mishandling in which additional bending of endobronchial tip occurred after stylet insertion process, resulting in bending angles are different.Unfortunately, ambu has not been able to get in contact with the reporter, which previously informed to have more information.Ambu will continue to get in contact with the initial reporter for more informaition.Corrective action has previously been implemented which enhance the bending inspection during assembly.Ambu production and quality control perform 100% inspection on each of the vivasight2 and it was verified in good condition prior shipment.Production, technical team and quality control have been made aware of this feedback via quality alert.Follow-up #1 mdr report 03/04/2026: additional information was received from the customer february 3rd, 2026 which included photos and lot number.The codes for "type of investigation codes" and "investigation findings" has been updated accordingly in h6.The reported failure (bending angles at the distal end of unused visi 2 dlts are different) is unverifiable from the photo shared by user as angle measurement was unable to be performed.No sample was returned either.The possible cause for reported failure could be due to patient-related factors (patient with difficult airway anatomy), resulting in there were difficulties advancing the tube.Corrective action has previously been implemented which enhance the bending inspection during assembly.Ambu production and quality control perform 100% inspection on each of the vivasight2 and it was verified in good condition prior shipment.Production, technical team and quality control have been made aware of this feedback via quality alert.
Event or Problem Description
The doctor pointed out to us that the bending angles at the distal end of unused visi 2 dlts are different.We compared different lot and item numbers.All items have been discarded by the hospital, no sample available.The doctor has furthermore, informed that during several intubations, there were difficulties advancing the tube after passing the vocal cords.The first photo shows the packaging with the label of one of the "problematic tubes." the other two photos show the (significant) difference in the bronchial curvature compared to a conventional competitor product (with which there are indeed no problems during placement).Comment from ambu: unfortunately, no photos or exact information on item numbers and lot numbers were provided by the doctor.Ambu has despite several follow-up attempts not been able to get in contact with him.Ambu have created the mdr report on vivasigth dlt kit size 37.On 3rd february 2026: additional information was recieved including lot numbers and pictures from the customer.

• 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.; lintang bayan lepas 6; phase iv, lot 69b; penang, 11900 ; MY 11900
• Manufacturer Contact: bolette walldorf ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 23971473
• Report Number: 9610691-2026-00001
• Device Sequence Number: 9012531
• Product Code: CBI
• UDI-Device Identifier: 05707480145737
• UDI-Public: 05707480145737
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 412371000
• Device Lot Number: 1001122105
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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
• Patient Sex: Unknown