MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0381
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
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
The customer reported that during an emergency care patient procedure, using a glidescope bflex 5.8 single-use bronchoscope, the bronchoscope got caught inside the patient's trach tube which ended up pulling the inner cannula out.The bronchoscope, inner cannula, and the trach tube had to be taken out all-together to remove the bronchoscope from the patient's airway.Upon removal the patient trach tube was eventually changed out.No harm to the patient or user was reported.
Additional Manufacturer Narrative
D9, g3, g6, h2, h3, h6, h10 the glidescope bflex 5.8 single-use bronchoscope used in the event was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and confirmed the reported issue.The verathon technical service representative performed a visual inspection and confirmed the camera was partially detached from the flexible tube on the glidescope bflex 5.8 single-use bronchoscope.Upon completion of the evaluation the glidescope bflex 5.8 single-use bronchoscope was scrapped.At this time, the cause of the reported issue could not be fully determined; however, it is likely that inserting the glidescope bflex 5.8 single-use bronchoscope into the inner cannula and tracheostomy tube in use with the patient at the time may have caused or contributed to the reported issue.The "glidescope bflex bronchoscope - endotracheal tube compatibility" table found on pg.16 in the glidescope bflex single-use bronchoscopes with glidescope core operations & maintenance manual (omm), currently only list the compatibility of the glidescope bflex single-use bronchoscopes with certain endotracheal tubes, double-lumen tubes, and airway catheters.The tracheostomy tube nor the inner cannula used in the procedure have not been validated by verathon for compatibility for use with the glidescope bflex single-use bronchoscopes.Any usage of the glidescope bflex bronchoscope outside of what is listed in the omm is outside of verathon's released labeling.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE BFLEX 5.8 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: 13416370
• Report Number: 9615393-2022-00013
• Device Sequence Number: 17259755
• Product Code: EOQ
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400(10)FT214500(17)221105
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K191948
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 11/05/2022
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT214500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Unknown