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.
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.
Additional Manufacturer Narrative
Initial mdr, august 28th, 2024: 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.Follow-up mdr #1, november 6th, 2024: recall report number added in h9 and "recall" ticked in h7.Confirmation received from fda that planned actions meets the criteria of a recall on october 30th, 2024.

• 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 69b; lintang bayan lepas 6; penang, 11900 ; MY 11900
• Manufacturer Contact: bolette walldorf ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 20085633
• Report Number: 9610691-2024-00016
• Device Sequence Number: 7688408
• Product Code: CBI
• UDI-Device Identifier: 05707480145737
• UDI-Public: 05707480145737
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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: Z-0261-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown