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	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, it is unknown if the reported device will be made available to verathon for further investigation, as it was last reported to be in possession of the facility's risk management team.Several attempts were made to follow-up on the return status of the reported device, but a response from the customer of the device's return has yet to be received.Information found on page 18 of the glidescope bflex single-use bronchoscopes for glidescope core: operation & maintenance manual (omm) currently provides a compatibility table for the glidescope bflex single-use bronchoscope use with endotracheal tube, double-lumen tube, and airway catheter only.Information provided for the use of the size 5.8 bflex single-use bronchoscope lists the 5.8 size being compatible with endotracheal tubes (et) only, with a "minimum inside diameter" of 7.0 mm.While the exact root cause of the reported event could not be fully determined, a possible cause for the reported tip separation could be due to the size of the tracheostomy tube that was reported to have been used with the glidescope bflex 5.8 single-use bronchoscope.Based on information provided, it is known that the glidescope bflex 5.8 single-use bronchoscope tip detached while in use with a 6.0 size shiley tracheostomy tube.While the exact model 6.0 size shiley tracheostomy tube is unknown, information found for 6.0 size shiley tracheostomy tubes indicates that they likely have an inner diameter (id) measurement of less than 7.0 mm.Therefore, the tracheostomy tube used with the glidescope bflex 5.8 single-use bronchoscope during the event may have been smaller than the minimum size 7.0 mm inner diameter recommended when endotracheal tubes are used with the bflex 5.8 single-use bronchoscope.Due to the inner diameter size difference, this may have potentially caused difficulties for the physician when attempting to remove the glidescope bflex 5.8 single-use bronchoscope from the 6.0 size shiley tracheostomy tube, likely causing the reported "shearing" of the bronchoscope during its attempted removal.As already stated, the omm provides compatibility requirements for the glidescope bflex single-use bronchoscopes with endotracheal tube, double-lumen tube, and airway catheter only.The tracheostomy tube used in the procedure currently has not been validated by verathon for compatibility for use with the glidescope bflex single-use bronchoscopes.Any usage of the glidescope bflex bronchoscope outside of what is listed in the omm is currently outside of verathon's released labeling.At this time, verathon continues to investigate the reported event and if any new information becomes available for the following device, a supplemental report will be submitted in accordance with 21 cfr 803.56.Verathon will continue to monitor for any ongoing trends.
Event or Problem Description
The customer reported that during a procedure to remove a large granuloma causing an airway obstruction on a very critical 65-year-old female patient, the physician first attempted to remove the airway obstruction by utilizing a glidescope bflex 3.8 single-use bronchoscope inserted into a 6.0 size shiley tracheostomy tube.The physician reported not being able to remove the obstruction using the glidescope bflex 3.8 single-use bronchoscope and switched to the larger size glidescope bflex 5.8 single-use bronchoscope in another attempt to remove the airway obstruction.The glidescope bflex 5.8 single-use bronchoscope was used, but again the procedure was reported as unsuccessful in removing the airway obstruction.An ent doctor was called in for consultation, and it was determined that the patient was to be sent to surgery.It was reported that no operating rooms were available at that time.At some point prior to surgery the glidescope bflex 5.8 single-use bronchoscope was removed from the 6.0 size shiley tracheostomy tube, and the tip was reported to have "sheared off" and fell inside the patient.The patient was reported to have passed prior to going into surgery.

• 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: 16410239
• Report Number: 9615393-2023-00040
• Device Sequence Number: 11604223
• Product Code: EOQ
• UDI-Device Identifier: 10879123006407
• UDI-Public: 011087912300640710FT22280017230708
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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: 07/08/2023
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT222800
• 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: 01/27/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female