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

Model Number	0570-0374
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope bflex 5.0 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned bronchoscope but was unable to reproduce the reported image issue.When the verathon technical service representative connected the returned bronchoscope to known, good, test verathon equipment, the bronchoscope functioned as intended.They confirmed the image did not turn black with fuzzy lines as reported.The camera image quality test was performed and passed for the glidescope bflex 5.0 single-use bronchoscope.Neither the verathon glidescope core monitor nor the verathon core quickconnect cable used with the glidescope bflex 5.0 single-use bronchoscope were made available for evaluation.Upon completion of the evaluation the returned glidescope bflex 5.0 single-use bronchoscope was scrapped, as it is a single-use device, and there currently are no repairs available for this device.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope, the image turned "black" with "fuzzy" lines appearing on the connected glidescope core monitor screen.The customer attempted to re-boot the glidescope core monitor several times, but it did not resolve the reported image turning "black" with "fuzzy" lines.The procedure was completed using another verathon glidescope core system and a new glidescope bflex 5.0 single-use bronchoscope, which was made available in an unspecified amount of time.After the procedure, based on troubleshooting the customer performed, the customer reported the issue may have been isolated to just the glidescope bflex 5.0 single-use bronchoscope initially used.There was no report of any harm to the patient during the procedure.

• Brand Name: GLIDESCOPE BFLEX 5.0 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: 15411200
• Report Number: 9615393-2022-00157
• Device Sequence Number: 5653052
• Product Code: EOQ
• UDI-Device Identifier: 10879123006339
• UDI-Public: 011087912300633910FS22300017230722
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

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: 07/22/2023
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS223000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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