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

Model Number	0600-0767
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	11/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement glidescope core quickconnect cable was provided to the customer and the cable used during the reported event was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the customer's cable but was unable to confirm the reported image issue.The tsr connected the customer's cable to verathon's test equipment and manipulated the cable, wiggled the connections, and rapidly detached and reattached each connection.No imaging issues were observed with any test device.The cable passed verathon's device functionality testing and confirmed to be within specification.Upon completion of verathon's device evaluation, the cable was scrapped due to the customer already being provided with a replacement cable.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that while using a glidescope core quickconnect cable during a patient procedure, the cable did not show the camera when inserted in the vent tube.The procedure was completed using a different cable from the hospital and was reported to have worked correctly.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE QUICKCONNECT 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: 20791714
• Report Number: 9615393-2024-00150
• Device Sequence Number: 15427315
• Product Code: CCW
• UDI-Device Identifier: 00879123006356
• UDI-Public: (01)00879123006356(11)210113
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 0600-0767
• Device Catalogue Number: 0800-0605
• Device Lot Number: 15046-1-7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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