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	Display or Visual Feedback Problem (1184); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during an emergency care patient procedure, using a glidescope bflex 3.8 single-use bronchoscope, the light on the bronchoscope went out.The customer attempted to unplug and re-plug the bronchoscope, but the light would not turn back on.The customer completed the procedure using a different manufacturer device.No harm to the patient or user was reported.
Additional Manufacturer Narrative
The customer's glidescope bflex 3.8 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported light issue.When connecting the glidescope bflex 3.8 to both a and b ports of a known, good, test monitor the led failed to illuminate.The led failure was also observed when the quick-connect cable ends were reversed.Upon completion of the evaluation, the subject glidescope bfflex 3.8 was scrapped and the customer was provided a replacement device.Corrective action is 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: 13581330
• Report Number: 9615393-2022-00022
• Device Sequence Number: 5526825
• Product Code: EOQ
• UDI-Device Identifier: 10879123006391
• UDI-Public: (01)10879123006391(10)FR213401(17)220820
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: 08/20/2022
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FR213401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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