MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE TITANIUM LOPRO T4 REUSABLE LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0127
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001); Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated; however, at the time of this 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.While the subject device has not been returned to verathon following this reported event, the device was evaluated in may 2025 for a separate issue which verathon confirmed and deemed the device unrepairable.A "not for human use" label was attached to the device and returned to the israeli importer as requested.The device was subsequently sent back to the hospital noting that the device could not be repaired and must be replaced.The facility continued using the device despite the "not for human use" label and instruction to replace the device.The glidescope video laryngoscopes operations and maintenance manual (omm) contains the following warning: "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.Always ensure that alternative airway management methods and equipment are readily available.".
Event or Problem Description
A facility reported during clinical use of a glidescope titanium lopro t4 reusable laryngoscope, the light source was functioning while outside the patient.However, once the blade was inserted into the patient, the light turned off, resulting in loss of visibility.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE TITANIUM LOPRO T4 REUSABLE LARYNGOSCOPE
• 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: 23065212
• Report Number: 9615393-2025-00104
• Device Sequence Number: 10044341
• Product Code: CCW
• UDI-Device Identifier: 00879123003171
• UDI-Public: (01)00879123003171(11)230926
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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 Number: 0574-0127
• Device Catalogue Number: 0574-0148
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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 Number: 1
• Patient Sex: Unknown