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)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope core smart cable, the image on the screen was flickering, freezing, and changing colors.The procedure was completed using an unknown backup device which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

A replacement glidescope core smart cable was provided to the customer and the subject glidescope core smart cable used during the reported procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned smart cable and was able to confirm the reported image failure.When connected to known, good, test verathon equipment, the smart cable was intermittently recognized.Furthermore, the metal shielding of the hdmi connector was missing.The customer's smart cable failed verathon's device functionality testing.The glidescope video laryngoscopes operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Upon completion of verathon's device evaluation, the smart cable was scrapped due to the customer already being provided a replacement and 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: 18184347
• MDR Text Key: 328696639
• Report Number: 9615393-2023-00209
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: (01)00879123006509(11)220111
• 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: 10/31/2023

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: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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