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

Model Number	0570-0381
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined to have their glidescope bflex 5.8 bronchoscope returned for evaluation and disposal.Since the bflex 5.8 bronchoscope was not returned to verathon for evaluation, the root cause of the event could not be determined.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 5.8 bronchoscope, the bronchoscope tip would flexed up and to the right but not straight up and down.The customer noted that the bronchoscope tip was not moving correctly when controlled by the handle.Instead of moving upward and staying centered, it would move up and to the right.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• 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: 11624280
• Report Number: 9615393-2021-00088
• Device Sequence Number: 3280390
• Product Code: EOQ
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400(10)FT210200(17)220108
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2021

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: 01/08/2022
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT210200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1