MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE TITANIUM VIDEO CABLE; LARYNGOSCOPE, RIGID

Model Number	0600-0616
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported while using a glidescope titanium video cable during a patient intubation, the video display went blank.The procedure was able to be completed with manual/direct intubation.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
The facility's glidescope titanium video cable was returned to verathon for evaluation along with the glidescope video monitor used during the procedure.A verathon technical service representative (tsr) evaluated the returned devices and was able to confirm the reported issue.The monitor passed visual inspection.When connected to verathon's test equipment, the monitor produced a normal image with no issues observed during testing.The monitor passed verathon's device functionality testing and confirmed to be within specification.Next, the tsr evaluated the returned video cable which failed visual inspection.The cable's connector housing was damaged and missing the connector lock.As a result, the cable would not stay connected to the test imaging device.The video cable failed verathon's device functionality testing.The glidescope video monitor 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 video cable was replaced and the monitor was returned to the facility as-is.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE TITANIUM VIDEO 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: 20182301
• Report Number: 9615393-2024-00118
• Device Sequence Number: 15519038
• Product Code: CCW
• UDI-Device Identifier: 00879123003201
• UDI-Public: 00879123003201
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: 0600-0616
• Device Catalogue Number: 0600-0616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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