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	05/05/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope spectrum single-use lopro s4 laryngoscope, the device initially displayed an image but then went black and wouldn't come back on.The procedure was completed using another glidescope spectrum single-use lopro s4, 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
A replacement for the glidescope spectrum single-use lopro s4 was provided to the customer and three glidescope spectrum single-use lopro s4 blades were returned to verathon for evaluation.It was unclear out of the three returned, which one was used during the reported patient procedure event.A verathon technical service representative evaluated the returned devices and was able to confirm a failure in one of the three returned devices.When connected to known, good, test verathon equipment, the failed device intermittently ceased to be recognized when manipulated.The other two returned blades functioned as normal when connected to known, good, test verathon equipment and manipulated.Upon completion of the evaluation the verathon technical service representative sent the customer's devices to verathon medical ulc office to be further investigated by a verathon sustaining engineer representative.If any new additional information becomes available regarding the following devices' investigation, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is currently not required at this time.Verathon continues to monitor for any ongoing trends.
Additional Manufacturer Narrative
Upon completion of the device evaluations by verathon's technical service department, which identified a failure in one of the three returned glidescope spectrum single-use lopro s4 blades, all three of the customer's devices were sent to the verathon medical ulc office to be further investigated by verathon's sustaining engineering department.A verathon sustaining engineer representative evaluated the customer's returned devices but was unable to reproduce the failure in any of the devices.When connected to known, good, test verathon equipment and manipulated, all three blades functioned as normal with no issues found.No further investigation or corrective action is required at this time.Verathon will continue to monitor for any ongoing 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: 14548470
• Report Number: 9615393-2022-00097
• Device Sequence Number: 20032127
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 07/19/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/28/2022; 07/26/2022
• 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