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	Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer has declined the option to have the glidescope bflex 5.0 single-use bronchoscope returned to verathon for evaluation at this time.Since the device was not returned to verathon for evaluation, the cause could not be determined.To date, no further information was provided regarding the reported incident despite follow-up attempts made to the customer as part of verathon's investigation of the reported event.Photo evidence initially provided by the customer shows the tip of the bronchoscope was damaged and missing the camera piece.While the exact root cause could not be determined, it is likely that the cause of the device failure was damage caused to the bronchoscope while inside the et tube.The manufacturer, model, and size of the et tube used with the glidescope bflex 5.0 single-use bronchoscope remains unknown.Review of production records for the glidescope bflex 5.0 single-use bronchscope, lot fs222600, 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 5.0 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.If further information becomes available, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope, the bronchoscope became lodged in the et tube upon removal.It was reported that the doctor pulled the scope to try and dislodge it, but once it was removed they noticed that the metal end piece was off and the end of the bronchoscope was stretched and torn.A x-ray was taken at the bedside and the object was shown in the patient's left mainstem bronchus.A ct scan was planned to better ascertain the location and the patient was brought to the or for retrieval of the metal piece.To date, no further information was made available regarding the status of the patient's condition.

• 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: 16507524
• Report Number: 9615393-2023-00049
• Device Sequence Number: 3301988
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS222600(17)230624
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS222600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 154 KG