MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0381
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope bflex 5.8 bronchoscope, the image was dark and pixelated while the bronchoscope was in the patient's mouth.The customer removed the bronchoscope and swapped it with a new one and was able to complete the case.A delay in the procedure of an undisclosed duration occurred as another bflex bronchoscope was obtained.No harm to the patient or user was reported.
Additional Manufacturer Narrative
A replacement glidescope bflex 5.8 bronchoscope was provided to the customer.The bflex 5.8 bronchoscope used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned bflex 5.8 bronchoscope and could not confirm the reported image issue.When the bflex 5.8 bronchoscope was connected to a known, good, test, glidescope core 15-inch monitor and a known, good, test, glidescope core quickconnect cable, the bflex 5.8 bronchoscope produced a normal image.The glidescope core quickconnect cable was connected and disconnected at the bflex end 15+ times, then a further 15+ times at the monitor end.The tests were repeated in both the a and b ports.The cable connection was reversed and the tests were repeated with the same results; no video image failure was detected.The camera image quality test was performed and passed.Since the glidescope bflex 5.8 bronchoscope was already provided to the customer, the bflex 5.8 bronchoscope used in the procedure was scrapped.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE BFLEX 5.8 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
• MDR Report Key: 12122768
• Report Number: 9615393-2021-00212
• Device Sequence Number: 20045677
• Product Code: EOQ
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400(10)FT211200(17)220318
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 03/18/2022
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT211200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1