MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD. BRITEPRO SOLO OMNI; LARYNGOSCOPE, RIGID

Catalog Number 040-04-0130U

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

Brite pro omni laryngoscope blade peeling off.Anesthesiologist noticed it prior in placing in patient's mouth.

• Brand Name: BRITEPRO SOLO OMNI
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.; 15281 barranca parkway; unit d; irvine CA 92618
• MDR Report Key: 8869281
• MDR Text Key: 153546310
• Report Number: 8869281
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-04-0130U
• Device Lot Number: 190300110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1