MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S4 (NS); LARYNGOSCOPE, RIGID

Model Number	0270-1079
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated; however, at the time of this 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
During a difficult intubation procedure, the customer reported that a glidescope spectrum single-use lopro s4, non-sterile (ns) blade produced no illumination when connected to a glidescope core 10-inch monitor and therefore the user could not see anything during the initial intubation attempt.The intubation was subsequently completed using another glidescope spectrum single-use lopro s4, ns blade, which was obtained within an unspecified amount of time.No patient harm was reported.
Additional Manufacturer Narrative
B4, d8, d9, g3, g6, h2, h3, h6, h11.The customer's glidescope spectrum single-use lopro s4, non-sterile (ns) blade was returned to verathon for evaluation.A verathon technical service representative evaluated the returned blade and was able to confirm the reported failure.When connected to both a test glidescope go monitor and a test glidescope core monitor, the blade's light-emitting diode (led) remained off.The device failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the blade was scrapped due to being a single-use device and there being no repairs available.Corrective action is not required at this time.Verathon will continue to monitor for ongoing trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S4 (NS)
• 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: 22895759
• Report Number: 9615393-2025-00096
• Device Sequence Number: 20284373
• Product Code: CCW
• UDI-Device Identifier: 00879123002761
• UDI-Public: (01)00879123002761(10)UU1014657(11)250320(17)280320
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 0270-1079
• Device Catalogue Number: 0574-0222
• Device Lot Number: UU1014657
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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: Male