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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 3.8 single-use bronchoscope, the device broke during intubation.The tip of the bronchoscope was lodged in the endotracheal (et) tube (shiley endobronchial tube left, size 39 fr) which was subsequently replaced with a backup et tube to complete the procedure.No delay in the procedure or harm to the patient was reported.Additional information received upon following up with the customer reported that the bronchoscope was being retracted from the et tube for the first time when the user felt resistance and the bronchoscope subsequently broke.The customer reported it is unknown if the bronchoscope was in a neutral position when it was being retracted and no lubrication was used.The glidescope bflex single-use bronchoscopes operations & maintenance manual (omm) states to lubricate the scope or tube prior to inserting the bronchoscope into the internal channel of the tube.If there is ongoing resistance, users should consider applying additional lubrication to the scope or tube.Furthermore, the omm states, "if you encounter resistance during withdrawal, reinsert the bronchoscope slightly, and then gently rotate it, straighten the tube, or instill saline into the tube, and then attempt removal again.".

• 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: 16583697
• Report Number: 9615393-2023-00047
• Device Sequence Number: 11171382
• Product Code: EOQ
• UDI-Device Identifier: 10879123006391
• UDI-Public: (01)10879123006391(10)FU224700(17)231118
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: 11/18/2023
• Device Model Number: 0570-0380
• Device Catalogue Number: 0570-0396
• Device Lot Number: FU224700
• 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: 02/22/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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