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

Model Number	0574-0187
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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 directview mac s3 video laryngoscope, the user experienced light loss/image loss during an intubation when the video laryngoscope was moved.The customer reported isolating the issue to the mac s3 video laryngoscope, itself, and not the cable or monitor it was used with during the procedure.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
Following the report submission on 10-may-2023 indicating that the reported glidescope spectrum single-use directview mac s3 video laryngoscope was accidentally disposed of after being received by verathon for evaluation, verathon was able to locate all 45 laryngoscopes returned by the customer from the subject lot number gv86159.A verathon technical service representative evaluated a sample (n=6) of the returned blades but was unable to confirm the reported image issue.When connected to known, good, test verathon equipment, the image quality was within specification and there was no identified loss of image or light when manipulating the connected cable.The sampled devices passed verathon's device functionality testing.To date, no further information has been reported to verathon regarding the reported event nor has verathon by made aware of any similar events from this customer.No further investigation is required at this time.Verathon will continue to monitor for trends.
Additional Manufacturer Narrative
The reported glidescope spectrum single-use directview mac s3 video laryngoscope was accidentally disposed of after being received by verathon for evaluation.Due to the accidental disposal of this device, it was not evaluated and verathon was unable to confirm nor deny the initial reported issue.While the exact cause could not be determined, a probable cause for the reported issue of "light loss/image loss when the video laryngoscope was moved" could potentially be a result of an intermittent hdmi connection between the reported video laryngoscope and the connected smart cable used at the time of the reported incident.Potential scenarios that may have led to the reported issue include damage sustained to the hdmi connector on the video laryngoscope and/or smart cable.It is also possible that the hdmi port on the video laryngoscope may not have been fully seated with the smart cable hdmi connector at the time of the reported incident.As the customer reported isolating the issue to the glidescope spectrum single-use directview mac s3 video laryngoscope, neither the glidescope spectrum smart cable nor the glidescope monitor used with the video laryngoscope during the reported incident were made available to verathon for evaluation.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S3
• 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: 16549890
• Report Number: 9615393-2023-00051
• Device Sequence Number: 6042742
• Product Code: CCW
• UDI-Device Identifier: 00879123006240
• UDI-Public: (01)00879123006240(10)GV86159(17)250620
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

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: 06/20/2025
• Device Model Number: 0574-0187
• Device Catalogue Number: 0270-0932
• Device Lot Number: GV86159
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 04/13/2023; 06/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/09/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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