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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE; LARYNGOSCOPE HANDLE, SINGLE USE
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FLEXICARE MEDICAL DONGGUAN 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 03/10/2021
Event Type  malfunction  
Event Description
During intubation laryngoscope handle has snapped where blade attaches to the handle.
 
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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
no. b-15 xicheng ind zone 1
hengli town
dongguan city, guangdong 52346 0
CH  523460
Manufacturer (Section G)
FLEXICARE MEDICAL DONGGUAN
no. b-15 xicheng ind. zone 1
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 Key11460423
MDR Text Key239138669
Report Number3006061749-2021-00005
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 Health Care Professional
Type of Report Initial
Report Date 03/11/2021
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 Catalogue Number040-310U
Device Lot Number201100821
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received03/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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