MAUDE Adverse Event Report: Gyrus ACMI, Inc. 200 MICRON TFL BALL TIP SINGLE USE FIBER; Powered Laser Surgical Instrument

Model Number	TFL-FBX200BS
Medical Device Problem Codes	Sparking (2595); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the laser of the subject device fired, it sparked and appeared to ignite/burn.There were no reports of patient harm/involvement.During the initial evaluation of the device, the reported event was unable to be confirmed.
Additional Manufacturer Narrative
The device was inspected on site via field service, and the reported failure was not confirmed.Based on the results of the investigation, a root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: 200 MICRON TFL BALL TIP SINGLE USE FIBER
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50876974
• Report Number: 3011050570-2026-00933
• Device Sequence Number: 15797709
• Product Code: GEX
• UDI-Device Identifier: 00821925043985
• UDI-Public: 00821925043985
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: TFL-FBX200BS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown