MAUDE Adverse Event Report: FLEXICARE MEDICAL LIMITED BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 0; LARYNGOSCOPE, RIGID

Model Number	040-06-0401U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Using 0 blade on 3kg baby.Less curve to the blade noted.The blade is displaced to the right.Nearly impossible to slide the endotracheal tube alongside the blade to maintain visualization of the vocal cords.Tube wants to slide into the blade completely obstructing view of the cords.Manufacturer response for laryngoscope, rigid, britepro omni single-use laryngoscope mini handle with miller 0 (per site reporter).Recommended we provide more education.

• Brand Name: BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 0
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LIMITED; 15281 barranca pkwy.; unit d; irvine CA 92618
• MDR Report Key: 20878028
• Report Number: 20878028
• Device Sequence Number: 8843452
• Product Code: CCW
• UDI-Device Identifier: 05055788773306
• UDI-Public: (01)05055788773306
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/30/2024
• Report Date (Section F): 09/30/2024

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: Health Professional
• Device Model Number: 040-06-0401U
• Device Catalogue Number: 040-06-0401U
• Device Lot Number: 2404 02232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• 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: Unknown
• Date Report Sent to FDA: 09/30/2024