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

Model Number 0570-0374

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope, the bronchoscope became lodged inside a 41 fr et tube and fractured when attempting to be removed.It was reported that the patient was extubated and reintubated with a new et tube to prevent the fractured portion of the bronchoscope from migrating and becoming a foreign body.No harm to the patient was reported.

Manufacturer Narrative

The customer declined the option to have the reported gldiescope bflex 5.0 single-use bronchoscope returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.No further information was made available regarding the reported incident despite numerous follow-up attempts as part of verathon's investigation.No lot number for the glidescope bflex 5.0 single-use bronchoscope was provided nor was the manufacturer/model of the 41 fr et tube used with the bronchoscope.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Trending analysis for the glidescope bflex 5.0 single-use bronchoscopes does not identify any trends exceeding acceptable limits.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: 16939852
• MDR Text Key: 315319555
• Report Number: 9615393-2023-00089
• Device Sequence Number: 1
• Product Code: EOQ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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