MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE VIDEO CABLE; LARYNGOSCOPE, RIGID

Model Number 0600-0771

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope core video cable, the display on the connected glidescope core 10-inch monitor turned black and presented a "no camera connected" message.The customer reported isolating the issue to the video cable.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

A replacement glidescope core video cable was sent to the customer and the reported video cable used in the procedure was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned video cable but was unable to confirm the reported image issue.When connected to known, good, test verathon equipment, the video image was normal.The glidescope core video cable passed verathon's device functionality testing.Neither the monitor nor the laryngoscope used with the video cable during the reported event were returned to verathon for evaluation.Upon completion of the evaluation, the device was scrapped due to the customer already being provided a replacement video cable.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE VIDEO CABLE
• 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: 17390001
• MDR Text Key: 319696354
• Report Number: 9615393-2023-00143
• Device Sequence Number: 1
• Product Code: CCW
• 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
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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