MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO MINI; LARYNGOSCOPE

Catalog Number 040-309U

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Second lot number also reported in complaint as below - lot: 200606055.Manufactured: 06-30-2023.Exp: 06-01-2023.Related to medwatch report: mw5116302.

Event Description

As described by initial reporter - "handle did not light when attached to the laryngoscope blade".

• Brand Name: BRITEPRO SOLO MINI
• Type of Device: LARYNGOSCOPE
• 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: 16972570
• MDR Text Key: 315642201
• Report Number: 3006061749-2023-00009
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/09/2023

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 Expiration Date: 12/30/2023
• Device Catalogue Number: 040-309U
• Device Lot Number: 181200040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• 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