MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0374
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
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 bedside percutaneous tracheotomy, using a glidescope bflex 5.0 bronchoscope, the picture kept freezing.The scope was removed and an unidentified reusable scope / tower was brought in to finish the procedure.No indication on how much time elapsed to get the back-up device into operation.No harm to the patient or user was reported.It should be noted that the glidescope bflex single use bronchoscope's operations and maintenance manual (omm) states that the bflex 5.0 bronchoscope can be inserted using any standard oral or nasal insertion technique.
Additional Manufacturer Narrative
A glidescope core quickconnect cable was returned to verathon for evaluation.There is no indication that the bflex 5.0 bronchoscope initially reported as the cause of the event was ever returned for evaluation.A verathon technical service representative evaluated the returned core quickconnect cable and was unable to confirm the video failure.The core quickconnect cable was connected to a known, good, test bflex bronchoscope and a known, good, test monitor and powered on.The video image was normal even when the quickconnect cable was manipulated.The technical service representative reversed the quickconnect cable connections and repeated the test with the same result; no problems found.The camera image quality test was performed and passed.The customer's glidescope core quickconnect cable was scrapped and a replacement was provided to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE BFLEX 5.0 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: 11784653
• Report Number: 9615393-2021-00120
• Device Sequence Number: 14238525
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS204500(17)211106
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183256
• 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): 04/09/2021

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: 11/06/2021
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS204500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1