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

Model Number	0574-0195
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received by verathon, however; at the time of the report the device has not been evaluated.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
A customer reported that during a patient procedure, using a glidescope spectrum single-use lopro s4 larygnoscope, the light on the blade failed to work and resulted in a loss of image.The procedure was completed using a backup glidescope spectrum single-use lopro s3 laryngoscope, which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
The customer's glidescope spectrum single-use lopro s4 laryngoscope was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned lopro s4 and was able to confirm the reported light failure.When connected to known, good, test verathon equipment, the tsr observed the light-emitting diode flickered.The customer's glidescope spectrum single-use lopro s4 larygnoscope failed verathon's device functionality testing.Upon completion of the evaluation, the device was scrapped due to there being no repairs available for the device.Corrective action is currently not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO 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: 17211010
• Report Number: 9615393-2023-00119
• Device Sequence Number: 6249238
• Product Code: CCW
• UDI-Device Identifier: 10879123006230
• UDI-Public: (01)10879123006230(10)GU80335(17)241027
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 10/27/2024
• Device Model Number: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: GU80335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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