MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0404

Device Problems Display Difficult to Read (1181); Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

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 Description

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the image was very dark and had green and red horizontal lines that went across the screen.The customer stated that they immediately unplugged the bronchoscope and plugged in a new glidescope bflex 5.8 bronchoscope.The image was still dark and had lines that would come and go.The customer then tried a glidescope bflex 5.0 bronchoscope and still had the same problem.The glidescope core quickconnect cable was switched to the b port and a new bflex 5.8 bronchoscope was plugged in.The image was normal with no issues.The customer did not report a delay in the procedure, use of a backup device, or harm to the patient or user.

Manufacturer Narrative

The glidescope core 15-inch monitor, a glidescope core quickconnect cable, two (2) glidescope bflex 5.8 bronchoscopes and one (1) glidescope bflex 5.0 bronchoscope were returned to verathon for evaluation.A verathon technical service representative connected the customer's returned core 15-inch monitor, core quickconnect cable and a known, good, test bronchoscope in both the a and b ports and the video image was normal.The connected ends of the core quickconnect cable were reversed, the test was reperformed and the video image remained normal.The customer's core 15-inch monitor and core quickconnect cable were connected to one (1) of the bflex 5.8 bronchoscopes and then the bflex 5.0 bronchoscope and the image was dark and discolored yellow.When the flexible tube of the bronchoscope was manipulated, lines appeared on the display.After connecting the customer's core 15-inch monitor and core quickconnect cable to the second bflex 5.8 bronchoscope the video image was normal.The technical service representative reconnected the first two (2) bflex bronchoscopes tested to the customer's core 15-inch monitor and core quickconnect cable and the video image was normal.The camera image quality test was performed and failed.The technical service representative determined that there was an intermittent image failure but was not able to fully determine its cause.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 11915659
• MDR Text Key: 257393072
• Report Number: 9615393-2021-00157
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 0570-0404
• Device Catalogue Number: 0270-1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1