MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number 0570-0374

Device Problems Off-Label Use (1494); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problems Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 307700461
• Report Number: 9615393-2022-00202
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 10879123006339
• UDI-Public: 011087912300633910FS2
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention