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

Model Number	0570-0381
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the customer and device information was not provided on the initial manufacturer and user facility report, a device analysis could not be completed for the specified device.The device history record (dhr) and non-conforming material (ncm) records were reviewed and no discrepancies were found.In addition, the complaint history for the lot number was reviewed with no additional complaints related to this lot.Should additional relevant information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
This issue was reported via manufacturer and user facility report number mw5099179 which stated that during a patient procedure, using a glidescope bflex 5.8 bronchoscope, the scope's outer sheath became detached.When the customer attempted to remove the scope, the sheath remained lodged in the endotracheal tube.The endotracheal tube had to be removed and patient re-intubated.No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE BFLEX 5.8 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: 11631620
• Report Number: 9615393-2021-00089
• Device Sequence Number: 11537698
• Product Code: EOQ
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400(10)FT201701(17)210424
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 04/24/2021
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT201701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1