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

Catalog Number	412371000
Medical Device Problem Codes	Difficult to Insert (1316); Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was possible to verify the reported failure (tip bent) fron the returned samples.Based on investigation performed, the excessive bending of the endobronchial tip was caused by operator mishandling during manufacturing in which additional bending of the endobronchial tip occurred after stylet insertion process.A capa has been initiated to further investigate the issue of excessive bending of endobronchial tip occuring during manufacturing.
Event or Problem Description
According to information from the customer.A patient needed to be urgently intubated with a dlt size 37.During the first attempt, mc grath was used, providing a good overview, but it was impossible to place the dlt due to a hyperangulated tip.It has been attempted beforehand, during preparation, to manually straighten the tip.During the second attempt, a new dlt size 37 was used, but the same problem occured.The intubator was changed, and the anesthesiologist forced the dlt through the vocal cords and trachea with great difficulty and hard pressure.No further impact to patient outcome was reported.

• 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, dnk 2750 ; DA 2750
• MDR Report Key: 20088934
• Report Number: 1220828-2024-00017
• Device Sequence Number: 7561795
• Product Code: CBI
• UDI-Device Identifier: 05707480145737
• UDI-Public: 05707480145737
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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: 1000958239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown