MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO MONITOR KIT; LARYNGOSCOPE, RIGID

Model Number 0570-0366

Device Problems Corroded (1131); Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

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.The glidescope and gliderite products reprocessing manual states: "use hospital-grade clean air to blow remaining moisture out of the connectors, and then dry the component using either hospital-grade clean air or a clean, lint-free cloth." it is likely that not blowing out the connector with hospital-grade air caused or contributed to the corrosion in the hdmi connector.

Event Description

The customer reported that during a patient procedure, using a glidescope go monitor, the image intermittently blacked out.On visual inspection, the glidescope go monitor's connector was noted as having a "little bit" of corrosion.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D4, d9, g3, g6, h2, h3, h4, h6, h10.The glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned go monitor and could not confirm the "intermittent image" failure.When the go monitor was tested with known, good, test equipment, the video image was normal.However, the technical service representative noted visible corrosion on the hdmi connector, which could lead to intermittent failure.The camera image quality test was performed and passed.The glidescope go monitor's hdmi connector was replaced and the device was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.The glidescope and gliderite products reprocessing manual states: "use hospital-grade clean air to blow remaining moisture out of the connectors, and then dry the component using either hospital-grade clean air or a clean, lint-free cloth." it is likely that not blowing out the connector with hospital-grade air caused or contributed to the corrosion in the hdmi connector.

• Brand Name: GLIDESCOPE GO MONITOR KIT
• 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: 12002836
• MDR Text Key: 261962059
• Report Number: 9615393-2021-00174
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0366
• Device Catalogue Number: 0570-0368
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1