MAUDE Adverse Event Report: GYRUS ACMI, INC. 550 MICRON TFL SINGLE USE FIBER

Model Number	TFL-FBX550S
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic bladder stone procedure, the 550 micron tfl single use fiber caught fire.The fire was extinguished, and the procedure was completed with a backup device.The customer reported that a laser device was used in the procedure, that oxygen was likely used by the anesthesia provider at the time of the event, and the presumed cause of the fire was a defective laser fiber.There was no patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated field(s): d4, d9, g4, h2, h3, h6, h11.The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the results of the investigation, the most probable cause of the complaint is cause traced to component failure.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
No additional information received from customer.

• Brand Name: 550 MICRON TFL SINGLE USE FIBER
• Common Device Name: 550 MICRON TFL SINGLE USE FIBER
• 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: 22521079
• Report Number: 3011050570-2025-00736
• Device Sequence Number: 20821111
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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-FBX550S
• Device Lot Number: KR403634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown