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

Model Number	0600-0783
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during an emergency care procedure using a glidescope core smart cable, the screen on the connected glidescope core 15-inch fhd monitor turns white and glitches when the laryngoscope touches the patient's tissue.The procedure was completed by doing a blind intubation.No delay in the procedure or harm to the patient was reported.Following the reported incident, the customer later reported that no image was observed at all when the unit was turned on.
Additional Manufacturer Narrative
The reported glidescope core smart cable was returned to verathon for evaluation along with the glidescope core 15-inch fhd monitor used during the reported event.A verathon technical service representative (tsr) evaluated the returned devices and confirmed the reported image issue.When connecting the monitor to verathon's test equipment, the display was not showing an image when the unit was powered on.Furthermore, it was found that the monitor's video cable was partially detached.The device failed verathon's visual inspection and device functionality testing.Next, the verathon tsr evaluated the returned smart cable and observed hdmi connector damage, specfically bent pins and plastic damage.The device failed verathon's visual inspection and was unable to be used with verathon's test equipment due to the identified connector damage; however, it is possible for smart cable connector damage to cause the reported image issues.Upon completion of verathon's device evaluation, the monitor's video cable was reseated and returned to the customer.The damaged smart cable was scrapped due to the customer already being provided a replacement cable 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: 20509037
• Report Number: 9615393-2024-00133
• Device Sequence Number: 15732673
• Product Code: CCW
• UDI-Device Identifier: 00879123006752
• UDI-Public: (01)00879123006752(11)231219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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