MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD BRITEPRO OMNI SIGNLE-USE LARYNGOSCOPE HANDLE WITH MAC2; LARYNGOSCOPE BLADE SIGNLE USE

Catalog Number 040-04-0120U

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

Britepro omni sterile single use laryngoscope handle (mac2) with batteries and fitted blade - light does not work.Britepro light failed.Dr used on a patient, he tested the device before intubation and when he inserted the laryngoscope the light went off and he lost visualization.

Manufacturer Narrative

The lot # provided in medwatch report # mw5109208 is 191101795, however this is incorrect the lot # for this device is actually 181101795.

• Brand Name: BRITEPRO OMNI SIGNLE-USE LARYNGOSCOPE HANDLE WITH MAC2
• Type of Device: LARYNGOSCOPE BLADE SIGNLE USE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 14546726
• MDR Text Key: 300789472
• Report Number: 3006061749-2022-00011
• 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: Other,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2022

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 Expiration Date: 10/01/2023
• Device Catalogue Number: 040-04-0120U
• Device Lot Number: 181101795
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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