MAUDE Adverse Event Report: GYRUS ACMI, INC. 200 MICRON TFL SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-FBX200S
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for investigation.A root cause could not be identified.Based on the product inspection, olympus confirmed the distal end tip broke off the wire and the insulation near the distal tip was worn, however, the most probable cause of the complaint is cause traced to component failure, it is likely due to stress of repeated use, external factors, or handling.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the single use fiber distal tip had broken off and the insulation near the distal tip appeared to have wear.There was no patient involvement.

• Brand Name: 200 MICRON TFL 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 ; 5082077661
• MDR Report Key: 25103851
• Report Number: 3011050570-2026-00505
• Device Sequence Number: 12013264
• Product Code: GEX
• UDI-Device Identifier: 00821925043947
• UDI-Public: 00821925043947
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: Other
• Device Model Number: TFL-FBX200S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/06/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown