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U.S. Department of Health and Human Services

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

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VERATHON MEDICAL ULC GLIDESCOPE CORE 10-INCH FHD MONITOR; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 0570-0436
Medical Device Problem Codes Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/24/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer's glidescope core system was not returned to verathon for evaluation, therefore the cause could not be determined.The customer was also unable to verify the laryngoscope used during the event.However, a verathon territory manager tested the system at the facility but was unable to replicate the reported issue.Follow-up information received from the customer confirmed there have been no reports of recurring issues since the reported event.Review of complaint history for the reported device did not identify any previous complaints reported to verathon.Trending analysis for glidescope core monitors 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.No further investigation is required at this time.Verathon will continue to monitor for trends.
 
Event or Problem Description
A customer reported while using a glidescope core 10-inch fhd monitor during a patient intubation, the screen went white twice.A backup device was used to complete the procedure.No procedural delay or patient harm was reported.
 
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Brand Name
GLIDESCOPE CORE 10-INCH FHD MONITOR
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 Key25636140
Report Number9615393-2026-00092
Device Sequence Number15840972
Product Code CCW
UDI-Device Identifier00879123008589
UDI-Public(01)00879123008589(11)230206
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,User Facility
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 06/26/2026
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 Model Number0570-0436
Device Catalogue Number0270-0996-FHD
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2026
Initial Report FDA Received Date06/26/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/06/2023
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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