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

Model Number 0570-0366

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Power Problem (3010)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

The customer reported that during an emergency care patient procedure, using a glidescope go monitor, the image went "black" whenever the connected verathon glidescope "handle" was lifted.The device was powered off and on again by the customer, and the image operated normally.A second attempt was made to intubate the patient, and the image disappeared again when lifting the connected verathon glidescope "handle." after the procedure, the customer reported disposing of the verathon glidescope "handle" due to contamination.No use of a backup device, or harm to the patient or user was reported.

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.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10 the reported glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor, and while they were unable to confirm the original reported image issue, they did confirm finding damage to the hdmi connector on the monitor.When connecting the reported glidescope go monitor to known, good, test verathon equipment, the video image was normal.The verathon technical service representative was unable to verify the image cutting out when the monitor's connector arm was manipulated.The camera image quality test was performed and passed.The verathon technical service representative next performed a visual inspection on the glidescope go monitor and reported that the monitor's hdmi connector was "pinched." they subsequently replaced the damaged hdmi connector on the monitor.Upon completion of the evaluation the glidescope go monitor was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE GO MONITOR
• Type of Device: LARYNGOSCOPE, 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: 14915600
• MDR Text Key: 295321333
• Report Number: 9615393-2022-00110
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: 010087912300618911210630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1