MAUDE Adverse Event Report: GYRUS ACMI, INC. 150 MICRON TFL BALL TIP SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-FBX150BS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device broke between the laser system and the scope -outside the scope and outside the patient.The issue was observed during an ureteroscopy with laser lithotripsy, after lasering the stone successfully for approximately 5 minutes, and completed with a similar device.A small mark was reported on the user¿s finger when the user came in contact with the active subject device.There was no report of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: h2, h3, h6, h11.The device was returned for evaluation and the customer's allegation was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause not established.Olympus will continue to monitor the performance of this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: 150 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 ; 5082077661
• MDR Report Key: 23405734
• Report Number: 3011050570-2025-01230
• Device Sequence Number: 17385125
• Product Code: GEX
• UDI-Device Identifier: 00821925043923
• UDI-Public: 00821925043923
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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-FBX150BS
• Device Lot Number: KR500036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown