MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0380
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 3.8 single-use bronchoscope, when removing the bronchoscope from the double lumen tube (37 fr shiley et tube), the bronchoscope became crimped on itself and then became stuck in the tube.When the bronchoscope was pulled out, the outer sheath was over the camera which led the md to take x-rays and perform another bronchoscopy to confirm that no pieces of the bronchoscope were left inside the patient.The customer confirmed that no pieces detached or fell inside the patient.There was no reported patient injury and they reported the patient was fine.
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
D9, g3, g6, h2, h3, h6, h10.The reported glidescope bflex 3.8 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and confirmed the reported damage by visual inspection.It was identified that the outer coating on the flexible tube of the bronchoscope was peeling off.It was also identified that the tube was kinked at the camera.Upon completion of the evaluation, the reported glidescope bflex 3.8 single-use bronchoscope was scrapped as it is a single-use device and there being no repairs available for this device.Trending analysis for glidescope bflex 3.8 single-use bronchoscopes did not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario is adequately captured and characterized.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE BFLEX 3.8 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: 15709677
• Report Number: 9615393-2022-00187
• Device Sequence Number: 4972309
• Product Code: EOQ
• UDI-Device Identifier: 10879123006391
• UDI-Public: 011087912300639110FR2
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 04/29/2023
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FR221800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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
• Patient Sex: Unknown