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 08/01/2023

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the picture on the screen froze when attempting to intubate the patient.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

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.

Manufacturer Narrative

The subject glidescope core smart cable used during the reported event was returned to verathon for evaluation.A verathon technical service representative evaluated the returned smart cable and was able to confirm the reported cable failure.Upon visual inspection, it was identified that the smart cable's hdmi connector was damaged by a blade retention pin.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.

Manufacturer Narrative

Following the submission of verathon's initial mdr, the customer notified verathon that they had isolated the issue to the glidescope core smart cable rather than the glidescope core 15-inch monitor.It was reported that the smart cable had a damaged prong in the hdmi connector, which was shown in a photo provided by the customer.Additionally, the customer reported that the incident occurred in (b)(6) 2023 but due to miscommunication within their facility, it was not reported to verathon until (b)(6) 2023.The event date and device details have been updated accordingly within this supplemental report.A replacement glidescope core smart cable was provided to the customer and the damaged glidescope core smart cable was requested to be returned to verathon for evaluation.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.

• 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: 18476614
• MDR Text Key: 332990129
• Report Number: 9615393-2024-00009
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: 010087912300663911200505
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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