MAUDE Adverse Event Report: FLEXICARE, INC. BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE HANDLE WITH MAC 2; LARYNGOSCOPE, RIGID

Model Number	040-04-0120U
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device has a short; when blade extended for use, light flickers on and off.

• Brand Name: BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE HANDLE WITH MAC 2
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE, INC.; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 9952992
• Report Number: 9952992
• Device Sequence Number: 2900699
• Product Code: CCW
• UDI-Device Identifier: 05055788768838
• UDI-Public: (01)05055788768838(17)231201(10)190102244
• 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): 03/10/2020
• Report Date (Section F): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 040-04-0120U
• Device Catalogue Number: 040-04-0120U
• Device Lot Number: 190102244
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/10/2020