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

Model Number	0600-0783
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement glidescope core smart cable was provided to the customer and the smart cable used during the reported event was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned smart cable and was able to confirm the reported damage.Upon visual inspection, it was identified that the smart cable's hdmi connector was damaged.The glidescope spectrum single-use mac laryngoscope used with the smart cable was not made available to verathon for evaluation nor was the backup glidescope device that reportedly kept freezing and flickering during its use.Upon completion of verathon's device evaluation, the customer's smart cable was scrapped due to 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 an emergency care procedure, using a glidescope core smart cable, the cable connector was damaged by a metal prong on the glidescope spectrum single-use direct view mac laryngoscope connector that was not flush with the laryngoscope handle.As the smart cable did not connect to the video laryngoscope, the team used a malfunctioning backup glidescope device that kept freezing and flickering during use.The procedure was able to be completed without harm to the patient.

• 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: 20025818
• Report Number: 9615393-2024-00108
• Device Sequence Number: 8601089
• Product Code: CCW
• UDI-Device Identifier: 00879123006752
• UDI-Public: (01)00879123006752(11)230327
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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