MAUDE Adverse Event Report: FLEXICARE INC. BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE, MILLER; LARYNGOSCOPE, RIGID

Model Number 040-310U, 040-309U

Device Problem Device Slipped (1584)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) of Esophagus (2398)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Patient inpatient since birth, when born with tricuspid valve atresia, right ventricle hypoplastic heart syndrome, right aortic arch, truncus arteriosus, heterotaxy.Patient had an inadvertent ett dislodgement and required reintubation.The disposable laryngoscope was used for the procedure.The plastic blade does not interface as well with the oropharynx and mucosa, making the blade slippery.The weight of the blade and handle is also different than metal blades, altering the technique required for intubation.In this instance, the epiglottis unexpectedly slipped off the blade and the surrounding mucosa easily fell around the blade, causing a laceration in the supraglottic region during intubation attempt.The blade does not easily move the supraglottic structures and mucosa.The led lighting against the blue blade causes a blue/purple hue within the oropharynx.These factors make it more challenging to identify anatomy and obtain a timely view of the cords for intubation.Bleeding quickly resolved.

• Brand Name: BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE, MILLER
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE INC.; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 15751628
• MDR Text Key: 303235542
• Report Number: 15751628
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2022

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: 040-310U, 040-309U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2022
• Event Location: Other
• Date Report to Manufacturer: 11/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA
• Patient Sex: Male
• Patient Weight: 3 KG