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); Retraction Problem (1536); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope, the scope got stuck upon removal and broke apart inside the et tube (39 fr double-lumen tube).All components of the scope were retained within the et tube and the tube was removed.X-rays were taken post-operatively as well as visual inspection of the entire area entered with no foreign bodies retained.No patient harm was reported.
Additional Manufacturer Narrative
The customer was unable to have their glidescope bflex 5.0 single-use bronchoscope returned to verathon for evaluation as it had been discarded at their facility.Since the device was not returned to verathon for evaluation, the exact root cause could not be determined.However, it is likely that inserting the glidescope bflex 5.0 single-use bronchoscope into the double-lumen tube used during the procedure may have caused or contributed to the reported issue.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.

• 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: 15709726
• Report Number: 9615393-2022-00192
• Device Sequence Number: 14738722
• Product Code: EOQ
• UDI-Device Identifier: 10879123006339
• UDI-Public: 011087912300633910FS214701172
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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: 11/19/2022
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS214701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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