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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 2M QUICKCONNECT CABLE; LARYNGOSCOPE, RIGID

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VERATHON MEDICAL ULC GLIDESCOPE CORE 2M QUICKCONNECT CABLE; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 0600-0843
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 10/31/2025
Type of Reportable Event Malfunction
Event or Problem Description
A customer reported while using a glidescope core 2m quickconnect (qc) cable on a patient in the operating room (or), the screen glitched and the image would go in and out.Inspection of the qc cable by a verathon representative found the magnet was missing inside one of the connectors.Furthermore, the corner of the connector was cracked.The qc cable was also found to have a label attached stating "positional." the customer reported completing the procedure using the second qc cable from the same glidescope core system which was made available in an unspecified amount of time.No harm to the patient was reported.
 
Additional Manufacturer Narrative
The customer's glidescope core 2m quickconnect cable was not returned to verathon for evaluation, therefore the cause of the reported issue could not be confirmed.However, based on inspection of the qc cable at the facility by a verathon representative and review of a photo provided, it is likely that the cause was due to the identified damage to the cable's qc connector.The glidescope core operations and maintenance manual (omm) notes, "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Review of complaint history for the reported qc cable was not able to be performed as the lot number was not provided.Trending analysis for glidescope core qc cables 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.Following the reported event, verathon was made aware that the customer ordered a replacement qc cable.Corrective action is not required at this time.Verathon will continue to monitor for trends.
 
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Brand Name
GLIDESCOPE CORE 2M QUICKCONNECT CABLE
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 Key23696385
Report Number9615393-2025-00133
Device Sequence Number9082734
Product Code CCW
UDI-Device Identifier00879123006578
UDI-Public00879123006578
Combination Product (Y/N)N
Initial Reporter StateTX
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,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/02/2025
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 Number0600-0843
Device Catalogue Number0800-0682
Device Lot NumberUNKNOWN
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 12/01/2025
Initial Report FDA Received Date12/02/2025
Was Device Evaluated by Manufacturer? (Y/N) Yes
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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