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); Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
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 that at the end of a therapeutic ureter lithotripsy and retrograde intrarenal surgery (rirs) procedure, the laser broke down.The procedure was completed with the same device.There was a 30 minutes delay to search for any potential fiber debris in the patient, but none was found.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's approved final investigation.The device was returned to olympus and the reported failure was confirmed.The fiber was separated into two parts and the device returned was missing approximately 70mm.A length discrepancy of approximately 10 cm was noted compared to the standard length of ~3.1 m stated on the packaging.The device was separated into two parts, and thermal damage was observed at on one broken end.The device exhibited a bending.The short broken piece measured approximately 538 mm, and the remaining fiber length was about 2492 mm.The total measured length was 3030 mm (standard length: 3.1 m), indicating a missing section of approximately 70 mm (7 cm).The root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: stress caused damage to the fiber at the bend.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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: 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: 22984240
• Report Number: 3011050570-2025-01016
• Device Sequence Number: 21174832
• Product Code: GEX
• UDI-Device Identifier: 00821925043947
• UDI-Public: 00821925043947
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFL-FBX200S
• Device Lot Number: KR482695
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TFL-PLS SOLTIVE PRO SUPERPULSED LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown