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

Model Number 0600-0783

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

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope core smart cable returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Review of complaint history for the reported smart cable serial number "(b)(6)" did not identify any previous complaints.Trending analysis for glidescope core smart cables does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during an emergency care procedure, using a glidescope core smart cable, the connected glidescope core monitor had no image and displayed a message indicating that no camera was connected even though a laryngoscope was connected.It was reported that this occurred in the middle of an intubation.The procedure was completed using a backup cable which was made available within a few minutes.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

Following verathon's initial report submission, the customer returned the subject glidescope core smart cable to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device and was able to confirm the reported cable failure.Upon visual inspection, the tsr identified two (2) bent pins inside the smart cable's hdmi connector.Due to the identified connector damage, the smart cable was unable to be connected to verathon's test equipment for evaluation of the reported image issue; however, it is likely that the damaged hdmi pins may have caused or contributed to the reported image issue.Upon completion of verathon's device evaluation, the customer's smart cable was scrapped due to there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• 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: 19073081
• MDR Text Key: 340567026
• Report Number: 9615393-2024-00063
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911211012
• 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: 03/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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