MAUDE Adverse Event Report: AMBU A/S VIVASIGHT 2 DLT KIT 39 FR - LEFT

Model Number	412391000
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Upper Respiratory Tract Injury (4599)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The incident leading to tonsil injuries occurred in two separate procedures (the second incident is covered by 9610691-2024-00023).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.
Additional Manufacturer Narrative
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.

• Brand Name: VIVASIGHT 2 DLT KIT 39 FR - LEFT
• Common Device Name: VIVASIGHT 2 DLT KIT 39 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: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 20850556
• Report Number: 9610691-2024-00024
• Device Sequence Number: 3758100
• Product Code: CBI
• UDI-Device Identifier: 05707480145768
• UDI-Public: 05707480145768
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Replace,Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: 412391000
• Device Catalogue Number: 412391000
• Device Lot Number: 1000989835
• 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: 11/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FDA REF.: Z-0261-2025, A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown