MAUDE Adverse Event Report: VERATHON MEDICAL ULC GS CORE 10-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0376

Device Problems Display or Visual Feedback Problem (1184); No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

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 Description

The customer reported that during a patient procedure, using a glidescope core 10-inch monitor, the image intermittently freezes for an extended period of time, upwards to around fifteen (15) minutes.The customer attempted to power cycle the monitor off and on, but reported being unable to do so.The procedure was completed using another verathon glidescope system, which was made available in an unspecified amount of time.No harm to the patient was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10.The reported glidescope core 10-inch monitor was returned to verathon for evaluation along with the glidescope core smart cable and glidescope video baton 2.0 used during the reported procedure.A verathon technical service representative evaluated the returned devices but was unable to confirm the initial reported image issues.When connecting the reported monitor to known, good, test verathon equipment, the image was normal; they were unable to confirm the freezing image issue.The camera image quality test was performed and passed for the monitor.No issues found for the glidescope core 10-inch monitor.Next the verathon technical service representative evaluated the returned glidescope core smart cable and glidescope video baton 2.0.When visually inspecting both the returned glidescope video baton 2.0 large and glidescope core smart cable, the verathon technical service representative reported finding no physical damage to the smart cable but did report finding damage to the video baton's lens and lens cover.The verathon technical service representative then took the returned video baton and smart cable and connected them together to a known, good, test verathon monitor; the video image produced from the test monitor was normal.The camera image quality test was performed and passed for both the glidescope video baton 2.0 large and glidescope core smart cable.Besides the damage found to the video baton, both the video baton and smart cable functioned as intended.Upon completion of the evaluation the customer was notified of the damage found to the glidescope video baton 2.0 large, with the recommendation to replace the video baton due to there being no repairs available for this device.Per request of the customer the glidescope video baton 2.0 large was returned "as-is" with their glidescope core 10-inch monitor and glidescope core smart cable.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GS CORE 10-INCH MONITOR
• Type of Device: 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: 15411197
• MDR Text Key: 305793369
• Report Number: 9615393-2022-00149
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911190722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0376
• Device Catalogue Number: 0270-0996
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1