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

Model Number	0600-0783
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
A customer reported while using a glidescope core smart cable, the light source on the connected laryngoscope went dark once inserted into the patient's mouth and thus no image could be seen.The procedure was completed using a backup device which was readily available in the room.No delay in the procedure or harm to the patient was reported.Follow-up information received from the doctor who performed the intubation stated the laryngoscope was functioning prior to intubation.During their subsequent troubleshooting of the device, they noticed that even though an image was transmitted from the laryngoscope, when moving the hdmi connection slightly, the light would turn on and off.The customer determined that the issue was isolated to the smart cable's hdmi connector.
Additional Manufacturer Narrative
B4, d8, d9, g3, g6, h2, h3, h6, h11.A replacement glidescope core smart cable was provided to the customer and the reported smart cabe used during the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported cable failure.Visual inspection identified damage to the cable's hdmi connector.Furthermore, the hdmi connector pins and metal sheath were found bent out of place.Due to the identified connector damage, the smart cable was unable to be used with verathon's test equipment.The glidescope core operations and maintenance manual (omm) notes, "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 customer's 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
• Common Device Name: 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: 22091911
• Report Number: 9615393-2025-00052
• Device Sequence Number: 7866657
• Product Code: CCW
• UDI-Device Identifier: 00879123006752
• UDI-Public: (01)00879123006752(11)221205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown