MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0194
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	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during intubation of a patient, using a glidescope spectrum single-use lopro s3 laryngoscope, they realized that the light on the laryngoscope did not turn on while it was connected.It was reported that once the laryngoscope was inserted into the patient it was then noticed that the picture was dark.No delay in the procedure, use of a backup device, or harm to the patient was reported.
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.
Additional Manufacturer Narrative
The reported glidescope spectrum single-use lopro s3 laryngoscope used during the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported issue.The device passed visual inspection.When connecting the reported device to verathon's test equipment, it produces a normal image; however the led does not illuminate.The glidescope spectrum single-use lopro s3 laryngoscope failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the lopro s3 was scrapped due to being a single-use device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 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: 20027069
• Report Number: 9615393-2024-00109
• Device Sequence Number: 8601639
• Product Code: CCW
• UDI-Device Identifier: 00879123006226
• UDI-Public: (01)00879123006226(10)GT1006577(11)240411(17)270411
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: GT1006577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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