MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE HANDLE MAC 4; BRITE PRO OMNI

Catalog Number 040-04-0140U

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

When lifting the valecula with the laryngoscope, light bulb would become too dim to see every time there was pressure on the blade.Another mac 4 laryngoscope was selected which worked appropriately.

• Brand Name: BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE HANDLE MAC 4
• Type of Device: BRITE PRO OMNI
• 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 LTD; 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 Key: 10790015
• MDR Text Key: 219599222
• Report Number: 3006061749-2020-00005
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2020

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 Number: 040-04-0140U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 75 YR