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

Model Number	0600-0783
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2023
Type of Reportable Event	Malfunction
Additional 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 issue.When connected to known, good, test verathon equipment, green, grainy artifacts and image cutout were observed when the cable was manipulated.The customer's smart cable failed verathon's device functionality testing.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.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core smart cable, the image was green and grainy when pressure was applied to the connected laryngoscope.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
**udi related data quality updates only** this is a supplemental report correcting the unique device identifier (udi) information in section d4.Following the initial report submission, it was identified that the udi information initially provided was incorrect.

• 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: 18131650
• Report Number: 9615393-2023-00210
• Device Sequence Number: 18080792
• Product Code: CCW
• UDI-Device Identifier: 00879123006752
• UDI-Public: (01)00879123006752(11)230808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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
• 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
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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