MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0380
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was unable to have the reported glidescope bflex 3.8 single-use bronchoscope returned to verathon for evaluation as it had already been discarded.Since the device was not returned to verathon for evaluation, the cause could not be determined.Review of the photo provided by the customer shows the tip of the bronchoscope inside one of the lumens of the 35 fr dlt; however, the exact cause of the bronchoscope being unable to advance through the dlt was not able to be determined based on the photo and limited information provided to date.The bflex single-use bronchoscopes operations & maintenance manual contains a bflex - endotracheal tube compatibility table along with a note stating, "there is no guarantee that instruments selected solely using these instrument dimensions will be compatible in combination.".Review of complaint history for glidescope bflex 3.8 single-use bronchoscopes lot number "fu231000" did not identify any similar complaints reported to verathon.Review of the device history record for the subject lot did not identify any anomalies that may cause or contribute to the reported event.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Trending analysis for the glidescope bflex 3.8 single-use bronchoscopes does not identify any trends exceeding acceptable limits.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 3.8 single-use bronchoscope, after inserting a 35 fr double lumen tube (dlt) into the patient and blocking the cuff, they were unable to pass the bronchoscope through the dlt at the point of the cuff.It was reported that the users replaced the 35 fr dlt with a larger 37 fr dlt which no longer gave them issues advancing the bronchoscope.The 35 fr dlt used during the procedure was manufactured by rüsch / teleflex.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• 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: 17090076
• Report Number: 9615393-2023-00101
• Device Sequence Number: 14974433
• Product Code: EOQ
• UDI-Device Identifier: 10879123006391
• UDI-Public: (01)10879123006391(10)FU231000(17)240310
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

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 Expiration Date: 03/10/2024
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FU231000
• 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: 05/24/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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