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 Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined the option to have their glidescope bflex 5.0 single-use bronchoscope returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the exact root cause could not be determined.However, based on additional information and photos received from the customer, it was identified that the glidescope bflex 5.0 single-use bronchoscope was used in combination with a covidien medtronic broncho cath endobronchial tube which is a double-lumen tube.Currently the bflex 5.0 bronchoscope does not support use with the double-lumen tube type.The "glidescope bflex bronchoscope - endotracheal tube compatibility" table found in the glidescope bflex single-use bronchoscopes operations & maintenance manual (omm) currently only lists the compatibility of the glidescope bflex single-use bronchoscopes with certain endotracheal tubes, double-lumen tubes, and airway catheters.The double-lumen tube used during the procedure has not been validated by verathon for compatibility for use with the glidescope bflex 5.0 single-use bronchoscope.Any usage of the glidescope bflex bronchoscope outside of what is listed in the omm is outside of verathon's released labeling.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported via medwatch form fda 3500a that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope, the distal components of the scope had broken off into the tracheal lumen of the double-lumen tube.The tip of the exterior shell of the scope had separated from the interior components.One lung ventilation was initiated without issue to prevent passage of the components further down the tracheal lumen.The object was removed from the tracheal lumen with assistance from interventional pulmonology.No patient harm was reported.

• 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: 14844673
• Report Number: 9615393-2022-00109
• Device Sequence Number: 4640347
• Product Code: EOQ
• UDI-Device Identifier: 10879123006339
• UDI-Public: 011087912300633910FS2
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 04/22/2023
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS221700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Black Or African American