MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0404
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	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
A customer reported while using a glidescope core 15-inch monitor with a glidescope bflex 5.0 single-use bronchoscope connected to the "a" port of the monitor during an aspiration procedure on a patient, the display suddenly went blank.The screen displayed a message indicating that no camera was connected.The procedure was completed by switching the bronchoscope and connected glidescope core quick connect cable from the "a" port to the "b" port which the core system then worked as intended.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
The subject glidescope core 15-inch monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported image issue.When connecting the monitor to verathon's test equipment, no loss of image was observed with either port "a" or "b." the monitor passed verathon's device functionality testing and confirmed to be within specification.The glidescope core quickconnect cable used during the reported incident was not made available to verathon for evaluation.Upon verathon following up requesting the cable to be returned for evaluation, it was reported that the customer confirmed the cable was working when used with other monitors and that they had isolated the issue to the monitor.The customer declined the option to have their cable returned for evaluation.Upon completion of verathon's device evaluation, the monitor was returned to the facility.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• 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: 20032472
• Report Number: 9615393-2024-00110
• Device Sequence Number: 12389172
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: (01)00879123006639(11)200602
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• 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: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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