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

Model Number 0600-0771

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 01/18/2024

Event Type  malfunction  

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.

Event Description

A customer reported that during a patient procedure, using a glidescope core video cable, the image turned green and fuzzy while placing an endotracheal tube in the patient's airway.The procedure was able to be completed without a backup device as it was reported that one person was holding the cable while another person inserted the laryngoscope.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

D8, d9, g3, g6, h2, h3, h6, h11 a replacement glidescope core video cable was provided to the customer and the subject glidescope core video cable used during the reported event was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video cable and was able to confirm the reported image issue.Upon visual inspection, the cable connector housing appeared damaged.When connected to known, good, test glidescope titanium laryngoscopes, a split image was produced.Manipulating the connection to the laryngoscope caused the image to freeze with horizontal green and pink lines.The customer's glidescope core video 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 video 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 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: 18697274
• MDR Text Key: 335317393
• Report Number: 9615393-2024-00023
• 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: Followup
• Report Date: 01/18/2024

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: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: 16670-1-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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