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	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that a glidescope spectrum directview mac s3 laryngoscope was connected to a glidescope system in preparation for intubation.It was reported that the light was working during pre-intubation checks; however, the light failed when the laryngoscope was inserted into the patient's mouth and pressure was applied to the laryngoscope for visualization of the vocal cords.The laryngoscope was removed from the patient which the light was then working when there was no pressure applied on the laryngoscope.A second attempt was made to intubate and the light failed again.The procedure was completed using a new laryngoscope which was used with no issues; however it resulted in a delay in intubating the patient.No 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 glidescope spectrum single-use directview mac s3 laryngoscope used during the reported event was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported light failure.When connected to verathon's test equipment, the light was confirmed to be working normally with multiple tests performed.However, visual inspection identified signs of damaged pins at the laryngoscope's hdmi connector.The device passed verathon's device functionality testing but failed visual inspection.The cable used with the laryngoscope during the reported event was not made available to verathon for evaluation.Based on prior engineering assessments, a potential cause of light failure may include an hdmi connection issue between the larynogscope and the connected cable.Review of complaint history for the reported mac s3 lot number "gv1001161" did not identify any previous complaints reported to verathon.Trending analysis for glidescope spectrum single-use laryngoscopes does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.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: 20086558
• Report Number: 9615393-2024-00114
• Device Sequence Number: 7599505
• Product Code: CCW
• UDI-Device Identifier: 00879123006240
• UDI-Public: (01)00879123006240(10)GV1001161(11)230922(17)260922
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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 Expiration Date: 09/22/2026
• Device Model Number: 0574-0187
• Device Catalogue Number: 0270-0932
• Device Lot Number: GV1001161
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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