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	Low Oxygen Saturation (2477)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported they were attempting to intubate a child (unknown age) with a glidescope spectrum single-use qc hyperangle s2 laryngoscope with a 4.5 mm endotracheal tube (ett) and a gliderite stylet (unknown size or model).It was reported that the laryngoscope had a great view but they could not see to safely pass the ett into the oropharynx as both the laryngoscope and ett could not fit in the child's mouth.After attempting minor adjustments with the c-collar in place and a different stylet, the patient started to desaturate at which point they decided to mask gently and then retry with a straight blade.A glidescope spectrum single-use qc miller s1 laryngoscope was connected but would not show the image.Both available cables were attempted but still no view or light displayed from the laryngoscope.They decided to revert back to using the hyperangle s2 laryngoscope which was inserted at the same time as the ett, with removal of the front of the c-collar and manual in-line stabilization of the head and neck.The ett was safely passed through the glottis.No harm to the patient was reported.
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 image failure.When connected to verathon's test equipment, the laryngoscope's led blinked three (3) times and shut off.No image produced on the test monitor, nor did the monitor recognize the laryngoscope being attached.The laryngoscope was reconnected to the test equipment which the led blinked twice and stayed illuminated.The test monitor recognized the laryngoscope was attached; however, the display showed a blank/black image.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 for trends.

• 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: 21405006
• Report Number: 9615393-2025-00020
• Device Sequence Number: 20963382
• Product Code: CCW
• UDI-Device Identifier: 00879123007971
• UDI-Public: (01)00879123007971(10)TF1010328(11)241121(17)271121
• 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): 01/22/2025

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: TF1010328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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