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 Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope bflex 5.0 single-use bronchoscope with a size 8.0 mm endotracheal tube, when removing the bronchoscope from the endotracheal tube the tip of the bronchoscope separated and went missing.All the customer saw at the end was a "yellow string".The customer immediately checked the airway of the patient with a new bronchoscope, but was unable to see anything inside the airway.A follow-up chest x-ray was performed on the patient, but did not reveal any foreign body in the patient's lungs.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
The device has been received by verathon, however; at the time of the report the device has not been evaluated.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
G3, g6, h2, h3, h6, h10.The glidescope bflex 5.0 bronchoscope as well as the shiley 8.0 mm endotracheal tube (ett) used in the procedure were returned to verathon for evaluation.A verathon sustaining engineer evaluated the returned device and confirmed that the distal tip, including the camera housing and metal coupler, had detached from the bronchoscope.In addition, it was observed that the returned bronchoscope was permanently deformed and ovalized approximately 275 mm from the distal end.The returned shiley 8.0 mm ett had prominent external and internal scuff marks along with damage to the print labeling on the tube at the 24 cm mark.The verathon engineer attempted to recreate the ovalization and tip detachment noted on the returned device.A unlubricated test glidescope bflex 5.0 bronchoscope was placed inside of a test shiley 8.0 mm endotracheal tube.A clamp was applied at the 275 mm mark of the bronchoscope and at the 24 cm mark of the endotracheal tube, to recreate the ovalization and damage noted in the returned sample.Following the placement of the clamp the bronchoscope was withdrawn from the endotracheal tube.A second sample test performed, this time using lubrication on the test bronchoscope.Following the sample tests the verathon engineer noted that the distal tip had detached from the braided shaft on both test bronchoscopes.In addition, deformation and ovalizing had occurred on both test bronchoscopes.Based off the evidence gathered from the returned bronchoscope, the returned endotracheal tube, and the test samples; the most likely cause of the distal tip detachment when removing the glidescope bflex 5.0 bronchoscope from a shiley 8.0 mm ett was due to the endotracheal tube inner diameter being narrower than normal.This was most likely caused by the patient biting down on the endotracheal tube during the intubation.The prominent scuff marks found at the 24 cm mark on the customer's shiley 8.0 mm ett shows signs of an external force being applied to the endotracheal tube, most likely caused by the patient's teeth biting down.At this time no additional corrective actions are required.Verathon will continue to monitor for trends.

• 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: 13231123
• Report Number: 9615393-2022-00009
• Device Sequence Number: 11840608
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS14200(17)221015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 10/15/2022
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS214200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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 Sex: Unknown