MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE QC HYPERANGLE S4; LARYNGOSCOPE, RIGID

Model Number	0574-0226
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	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remaining single-use laryngoscopes from the same lot as the one used during the reported event were returned to verathon for evaluation along with the customer's glidescope core monitor and glidescope core quickconnect cables.A verathon technical service representative (tsr) evaluated the returned devices but was unable to confirm the reported failure.When connected to verathon's test equipment, no image issues were observed with the laryngoscopes.The tsr wiggled the connection points, manipulated the cable, unplugged and re-plugged the blades multiple times, and tried each laryngoscope on both connection ports of the monitor.Next, the customer's cables and monitor were used with test laryngoscopes and no issues were found.The customer's single-use laryngoscopes, cables, and monitor passed verathon's device functionality testing.It is unknown if the specific laryngoscope used during the reported event was returned to verathon for evaluation.Upon completion of verathon's device evaluation, the single-use laryngoscopes were scrapped due to the customer already receiving replacements.The cables and monitor were returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for ongoing trends.
Event or Problem Description
A customer reported while intubating a patient, using a glidescope spectrum single-use qc hyperangle s4 laryngoscope, the image was glitchy and going in and out.The doctor reported switching the cable during the procedure but continued experiencing similar problems.No delay in the procedure or harm to the patient was reported.After successfully intubating the patient following the reported incident, the facility did further troubleshooting and isolated the issue to the single-use laryngoscope.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE QC HYPERANGLE S4
• 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: 20509328
• Report Number: 9615393-2024-00137
• Device Sequence Number: 7969285
• Product Code: CCW
• UDI-Device Identifier: 00879123007933
• UDI-Public: (01)00879123007933(10)TB99420(11)230515(17)241115
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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 Expiration Date: 11/15/2024
• Device Model Number: 0574-0226
• Device Catalogue Number: 0270-1084
• Device Lot Number: TB99420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown