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

Model Number 040-309U

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

Handle did not light when attached to the laryngoscope blade.Two lot numbers involved: 181200040 and 20060655 (11 of this lot did not work).Reference report: mw5116301.

• Brand Name: BRITEPRO SOLO
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL, LTD.
• MDR Report Key: 16682466
• MDR Text Key: 312802683
• Report Number: MW5116302
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/03/2023

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
• Device Operator: Health Professional
• Device Model Number: 040-309U
• Device Lot Number: 181200040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Ethnicity: Hispanic