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

Model Number	TFL-FBX550S
Medical Device Problem Codes	Fire (1245); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the single use fiber exhibited a burning fiber smell.The issue occurred during an unspecified transurethral resection procedure of prostate using thulium laser.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation/inspection.Based on the results of the investigation, the burn could not be identified.A definitive root cause could not be established.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
No additional information received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction and additional information to a previously submitted report.Corrected field: h6.Updated fields: h7 and h9.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
No additional information received from the 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: 24548312
• Report Number: 3011050570-2026-00251
• Device Sequence Number: 18488323
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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: KR502889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/17/2026; 06/25/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/18/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011050570-04/17/2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown