MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE

Model Number	0570-0380
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported via medwatch report number mw5144971 that during a dual-lumen intubation, using a glidescope bflex 3.8 single-use bronchoscope, the end of the bronchoscope broke off in the patient's bronchus.Another scope was used to retrieve the broken piece which was reported as being hollow plastic approximately 4-5 mm in diameter and 1.5-2 cm in length.No harm to the patient was reported.
Additional Manufacturer Narrative
The reported glidescope bflex 3.8 single-use bronchoscope used during the reported event was not returned to verathon for evaluation.Since the device was not made available for evaluation, the cause could not be determined.Verathon followed up with the customer requesting additional information including the type of double lumen tube utilized with the bronchoscope during the dual-lumen intubation; however, no information was provided.Review of complaint history for the reported lot number "fu231800" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope bflex 3.8 single-use bronchoscopes does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 17913126
• Report Number: 9615393-2023-00196
• Device Sequence Number: 6777417
• Product Code: EOQ
• UDI-Device Identifier: 10879123006391
• UDI-Public: 011087912300639110FU23180017240505
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/12/2023

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 Expiration Date: 05/05/2024
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FU231800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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: Required Intervention
• Patient Sex: Unknown