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 Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
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, when pulling the bronchoscope out of the double lumen tube (41 fr shiley), the camera tip had detached and the distal tip of the bronchoscope was frayed.The physician clamped the tracheal side of the double lumen tube to ensure the forced positive air didn't push anything into the patient's right lung.They worked to safely oxygenate the patient through the bronchial side of the tube.The patient was extubated and reintubated with a 39 fr dlt and a different manufacturer scope.The physician performed a diagnostic view of the right lung bronchi with no reported injury or foreign body.A forceps was used to remove the lodged camera from the distal tip of the 41 fr dlt.X-rays were taken and confirmed no foreign bodies or injury to the patient.
Additional Manufacturer Narrative
The reported glidescope bflex 5.0 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and confirmed the reported damage and detached camera.It was determined that the likely root cause of the reported issue is due to inserting the glidescope bflex 5.0 single-use bronchoscope into the double lumen tube used during the procedure.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.Upon completion of the evaluation, the reported glidescope bflex 5.0 single-use bronchoscope was scrapped as it is a single-use device and there being no repairs available for this device.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: 15753241
• Report Number: 9615393-2022-00202
• Device Sequence Number: 16889904
• Product Code: EOQ
• UDI-Device Identifier: 10879123006339
• UDI-Public: 011087912300633910FS2
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 03/18/2023
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS221200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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: Required Intervention
• Patient Sex: Unknown