MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE

Model Number	0570-0381
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The facility did not retain the subject glidescope bflex 5.8 single-use bronchoscope following the reported event and therefore was not available to be returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Photo evidence provided by the facility shows the tip of the bronchoscope was damaged and missing the camera/tip.Upon following up with the facility for additional information as part of verathon's investigation of the reported event, the facility was unable to confirm the manufacturer and model of the et tube used with the bronchoscope during the procedure.However, they reported that the user experienced difficulty passing the bronchoscope through the et tube due to a bronchial block in place.Review of production records for the glidescope bflex 5.8 single-use bronchscope, lot number "fw223400", did not identify any anomalies.Review of complaint history for the reported lot did not identify any other complaints reported to verathon.Trending analysis for the glidescope bflex 5.8 single-use bronchoscopes does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.
Event or Problem Description
A user facility reported via medwatch report number (b)(4).That during a bronchoscopy done at the bedside by an intesivist in the intensive care unit (icu), the tip of the glidescope bflex 5.8 single-use bronchoscope being used broke off inside the patient.Upon following up with the facility regarding the reported event, the facility reported that the tip broke when being retracted from the et tube.It was reported that the user experienced difficulty passing the bronchoscope through the et tube due to a bronchial block in place.The manufacturer and model of the et tube was not provided.The detached tip was successfully removed by a pulmonologist.No further medical treatment or hospitalization was required for the patient due to the reported bronchoscope tip separation; however, due to the patient already being in a critical condition, they were on extracorporeal membrane oxygenation (ecmo).

• Brand Name: GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE
• 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: 17730350
• Report Number: 9615393-2023-00170
• Device Sequence Number: 6164499
• Product Code: EOQ
• UDI-Device Identifier: 10879123006407
• UDI-Public: 011087912300640710FW22340017230819
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FW223400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG