MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD 040-341U BRITEPRO SOLO SINGLE-USE FIBER OPTIC HANDLE AND BLADE MILLER 1; LARYRNGOSCOPE

Catalog Number	040-341U
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No serious injury/harm to patient or user reported.No indirect harm reported.No required intervention to prevent permanent damage reported.No hospitalization - intial or stay prolonged by 1 day or more reported.No serious injury, disability or permanent impairment reported.Not reported as life threating.No death reported.This was informed based on maude database but could not be located on maude database therefore this is a report for a customer report that may not exust but as such we are precautionarily reporting it.
Event or Problem Description
The blade light failed when checked prior to use on patient no patient harm or risk.

• Brand Name: 040-341U BRITEPRO SOLO SINGLE-USE FIBER OPTIC HANDLE AND BLADE MILLER 1
• Common Device Name: LARYRNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, CF454 ER; UK CF454ER
• Manufacturer Contact: robert foxwell ; cwm cynon business park; mountain ash, CF454-ER ; UK CF454ER
• MDR Report Key: 22554778
• Report Number: 3006061749-2025-00020
• Device Sequence Number: 9576512
• Product Code: CCW
• UDI-Device Identifier: 05055788724063
• UDI-Public: 05055788724063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 Catalogue Number: 040-341U
• Device Lot Number: 190402252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown