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

Model Number	0570-0381
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined the option to have the reported glidescope bflex 5.8 single-use bronchoscope returned to verathon for evaluation.It was reported by the customer that the device had already been discarded on-site at their facility.Since the device was not returned to verathon for evaluation, the root cause could not be determined.Corrective action is not 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 5.8 single-use bronchoscope, the image froze several times and then the image disappeared displaying a black screen.The customer reported unplugging/re-plugging the glidescope bflex 5.8 single-use bronchoscope up to three (3) times unsuccessfully in order to get the image to reappear on the connected video monitor.The procedure was completed using a new glidescope bflex single-use bronchoscope, which was made available in an unspecified amount of time.No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE BFLEX 5.8 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: 14548464
• Report Number: 9615393-2022-00105
• Device Sequence Number: 5172010
• Product Code: EOQ
• UDI-Device Identifier: 10879123006407
• UDI-Public: (01)10879123006407(10)FT215300(17)221231
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 12/31/2022
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT215300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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