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

Model Number 0600-0783

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received by verathon, however; at the time of the report the device has not been evaluated.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.Reference the attached corresponding report containing the device information for the customer's returned glidescope go monitor which was also reported as experiencing the same image issues during the reported event.

Event Description

A customer reported that during a patient procedure, using a glidescope core smart cable, the video on the connected glidescope core 10-inch monitor became pixelated and blanked out intermittently when the cable and laryngoscope were manipulated.The procedure was completed using a backup glidescope go monitor but they reported experiencing the same intermittent image issues with the backup glidescope go monitor and several different laryngoscopes.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

While the reported glidescope core smart cable was not returned to verathon for evaluation, the glidescope core 10-inch monitor (serial number: (b)(6)) used with the glidescope core smart cable was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported failure.The monitor passed visual inspection and when connected to multiple known, good, test verathon equipment, the monitor produced a normal image with no observed failures.The glidescope core 10-inch monitor passed all verathon device functionality testing.Upon completion of verathon's device evaluation, the monitor was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.Reference the attached corresponding report containing the device evaluation findings for the customer's glidescope go monitor which was also reported as experiencing the same image issues during the reported event.

• Brand Name: GLIDESCOPE CORE SMART 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: 18221490
• MDR Text Key: 329336800
• Report Number: 9615393-2023-00220
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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