MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD. BRITEPRO SOLO SINGLE-USE FIBER OPTIC HANDLE AND BLADE MILLER 1; LARYNGOSCOPE, RIGID

Model Number	040-341U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The blade light failed when checked prior to use on patient.

• Brand Name: BRITEPRO SOLO SINGLE-USE FIBER OPTIC HANDLE AND BLADE MILLER 1
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.; 15281 barranca pkwy unit d; irvine CA 92618
• MDR Report Key: 18570677
• Report Number: 18570677
• Device Sequence Number: 20894890
• Product Code: CCW
• UDI-Device Identifier: 05055788724063
• UDI-Public: (01)05055788724063(17)240301(10)190402252
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2023
• Report Date (Section F): 10/06/2023

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: Other
• Device Model Number: 040-341U
• Device Lot Number: 190402252
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• 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: Male
• Patient Weight: 10 KG
• Date Report Sent to FDA: 10/06/2023