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 Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope bflex 5.0 single-use bronchoscope used in the event was returned to verathon for evaluation.On visual inspection by the verathon technical service representative they were able to confirm the reported damage; the tip of the bronchoscope was loose inside the bag it was received in.Upon completion of the evaluation the reported glidescope bflex 5.0 single-use bronchoscope was scrapped.At this time, the cause of the reported issue could not be fully determined; however, it is likely that inserting the glidescope bflex 5.0 single-use bronchoscope into a incompatible double-lumen tube may have caused or contributed to the reported issue.The "glidescope bflex bronchoscope endotracheal tube compatibility" table found on pg.16 in the glidescope bflex single-use bronchoscopes with glidescope core operations & maintenance manual (omm), currently list the use of a glidescope bflex 5.0 single-use bronchoscope with a double-lumen tube as "not supported".Any usage of the glidescope bflex 5.0 single-use bronchoscope with a double lumen-tube is considered 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
The customer reported that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope with a double-lumen tube, a piece of plastic from the bronchoscope broke off and retained in the patient's airway.A therapeutic bronchoscopy was performed in combination with the use of bronchoscope alligator forceps / graspers to remove the broken bronchoscope piece successfully.No harm to the patient or user 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: 13636467
• Report Number: 9615393-2022-00030
• Device Sequence Number: 20102731
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS211100(17)220312
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS211100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown