MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO; LAYRYNOSCOPE

Catalog Number 040-310U

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Event as described by complainant below : "when going to intubate a patient in the er during a trauma situation, the handle used would the light would not work.4 additional handles were checked and they also did not work.The changed to use a mini handle, which worked fine.David checked his crash carts and found additional handles not working.He said he has at least 8 handles he can return.".

• Brand Name: BRITEPRO SOLO
• Type of Device: LAYRYNOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL LTD (CHINA); no.b-15; xicheng industrial zone; dongguan, guangdong 52346 5; CH 523465
• Manufacturer Contact: alex mcdonough ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 16972584
• MDR Text Key: 315650382
• Report Number: 3006061749-2023-00011
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-310U
• Device Lot Number: 200600734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1