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 Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 3.8 single-use bronchoscope, there was no image on the monitor.The procedure was completed using a backup glidescope bflex single-use bronchoscope which delayed the procedure by ten (10) minutes.No harm to the patient was reported.
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
The reported glidescope bflex 3.8 single-use bronchoscope used during the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned bronchoscope and was able to confirm the reported image issue.When connecting the reported bronchoscope to known, good, test verathon equipment, it failed to be recognized by the test monitor.The glidescope bflex 3.8 single-use bronchoscope failed verathon's device functionality testing.Upon completion of the evaluation, the device was scrapped due to being a single-use device and there being no repairs available.Corrective action is currently not required at this time.Verathon will continue to monitor for trends.

• 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: 16762163
• Report Number: 9615393-2023-00075
• Device Sequence Number: 2933788
• Product Code: EOQ
• UDI-Device Identifier: 00879123006394
• UDI-Public: (01)00879123006394(10)FR220800(17)230218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 02/18/2023
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FR220800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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
• Patient Sex: Unknown