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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE INC. BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID
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FLEXICARE INC. BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 040-309U
Device Problems Collapse (1099); Positioning Problem (3009)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2022
Event Type  malfunction  
Event Description
When attempting to set up the laryngoscope for intubation, the size 0 blade on the new disposable handle the blade would not stay locked into position.The blade locked into position; then when opening it, it would not stay in position, instead fell/collapsed.After several times of opening it and after forcefully pushing down while opening, it would stay open enough to keep the light on, but still would easily fall back down if it touched any part of the patient's mouth upon use.
 
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Brand Name
BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
FLEXICARE INC.
15281 barranca pkwy, unit d
irvine CA 92618
MDR Report Key15751729
MDR Text Key303259653
Report Number15751729
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number040-309U
Device Lot Number211202401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2022
Event Location Hospital
Date Report to Manufacturer11/08/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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