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

Model Number 040-04-0120U

Device Problem Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

Event Type  malfunction  

Event 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
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE, INC.; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 9952992
• MDR Text Key: 187391421
• Report Number: 9952992
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 05055788768838
• UDI-Public: (01)05055788768838(17)231201(10)190102244
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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