MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0570-0381
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope bflex 5.8 bronchoscope was returned to verathon for evaluation.A verathon representative evaluated the returned bflex 5.8 bronchoscope and was unable to confirm the "frozen image" issue.The bflex 5.8 bronchoscope was connected to a known, good, test core 10-inch monitor and the image remained stable when the connector and the shaft were manipulated.No further investigation is 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 5.8 bronchoscope, the screen froze when the bronchoscope was being inserted into the endotracheal tube.The customer was able to reset the screen by unplugging and re-plugging the glidescope quickconnect cable.Within a few seconds, as they continued to insert the bflex bronchoscope into the endotracheal tube, the screen froze again.A delay of an unspecified duration occurred as a backup glidescope bflex 5.8 bronchoscope was obtained.No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 11882006
• Report Number: 9615393-2021-00145
• Device Sequence Number: 3710601
• Product Code: CCW
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400(10)FT203200(17)210807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 08/07/2021
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT203200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1