MAUDE Adverse Event Report: FLEXICARE, INC. BRITEPRO SOLO; LARYNGOSCOPE, RIGID

Catalog Number 040-341U

Device Problems Device Operates Differently Than Expected (2913); Light Interference (2972)

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

Event Date 05/11/2016

Event Type  malfunction  

Event Description

During an intubation attempt, the blade light on the scope (2 blades used) turned off making intubation difficult.Another blade was used.The patient was currently on pippv; intubation was successful.

• Brand Name: BRITEPRO SOLO
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE, INC.; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 5815028
• MDR Text Key: 50183096
• Report Number: 5815028
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 040-341U
• Device Lot Number: 150500862
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR