MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS 200 MICRON THULLIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number TFL-FBX200S

Device Problems Fire (1245); Fracture (1260)

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

Event Date 01/05/2023

Event Type  malfunction  

Event Description

Surgeon was using the 200micron single use olympus thullium laser after 5:36 minutes of use the fiber fractured which created a flame at the area of the fiber where the fiber connects to the hub which connects to the laser machine.

• Brand Name: 200 MICRON THULLIUM LASER FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy; center valley PA 18034 8229
• MDR Report Key: 16379176
• MDR Text Key: 309578552
• Report Number: MW5114932
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2023

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 Model Number: TFL-FBX200S
• Device Lot Number: MDUF200140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1