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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope bflex 3.8 single-use bronchoscope complaint sample was not returned to verathon for evaluation.Sample testing with a glidescope bflex 3.8 bronchoscope and shiley 35fr endobronchial tube (et) was conducted.A root cause could not be conclusively determined.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope bflex 3.8 single-use bronchoscope, upon extraction of the bronchoscope, the anesthesiologist encountered resistance removing the insertion tube.Upon removal, the distal tip detached inside the double-lumen tube (dlt) at the bifurcation of the bronchial and trachea lumens.The patient required extubation and re-intubation as a result.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• 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
• MDR Report Key: 10280553
• Report Number: 9615393-2020-00152
• Device Sequence Number: 2623913
• Product Code: EOQ
• UDI-Device Identifier: 00879123006394
• UDI-Public: (01)00879123006394(10)FR200400(17)210127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 01/27/2021
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FR200400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention