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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE; LARYNGOSCOPE HANDLE, SINGLE USE
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FLEXICARE MEDICAL DONGGUAN LTD BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE; LARYNGOSCOPE HANDLE, SINGLE USE Back to Search Results
Catalog Number 040-310U
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  malfunction  
Event Description
During intubation, laryngoscope handle broke, and small metal piece that holds the blade on fell into the patient's mouth.The piece was retrieved without any patient harm.
 
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Brand Name
BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE
Type of Device
LARYNGOSCOPE HANDLE, SINGLE USE
Manufacturer (Section D)
FLEXICARE MEDICAL DONGGUAN LTD
no. b-15 xicheng ind zone 1
hengli town
donnguan city, guangdong 52346 0
CH  523460
Manufacturer (Section G)
FLEXICARE MEDICAL DONGGUAN LTD
no. b-15 xicheng ind zone
hengli town
dongguan city, guangdong 52346 0
CH   523460
Manufacturer Contact
darryl ridge
cynon valley business park
mountain ash, rct CF45 -4ER
UK   CF45 4ER
MDR Report Key10842270
MDR Text Key216343513
Report Number3006061749-2020-00009
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number040-310U
Device Lot Number200704301
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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