MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE QC MILLER S1 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0231
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	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope spectrum single-use qc miller s1 laryngoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported light failure.The device passed visual inspection.When connected to verathon's test equipment, the laryngoscope produced a normal image.However, the laryngoscope's led failed to illuminate.The glidescope spectrum single-use qc miller s1 laryngoscope failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the laryngoscope 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 trends.
Event or Problem Description
A customer reported that during a routine patient intubation, using a glidescope spectrum single-use qc miller s1 laryngoscope, the light source did not work.It was reported that the image was dark upon inserting the blade into the patient's mouth.Subsequently, the doctor opted to complete the intubation via direct laryngoscopy.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE QC MILLER S1 LARYNGOSCOPE
• 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: 21634254
• Report Number: 9615393-2025-00030
• Device Sequence Number: 18519506
• Product Code: CCW
• UDI-Device Identifier: 00879123007971
• UDI-Public: (01)00879123007971(10)TF1012696(11)241204(17)271204
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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: 0574-0231
• Device Catalogue Number: 0270-1088
• Device Lot Number: TF1012696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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