MAUDE Adverse Event Report: Gyrus ACMI, Inc. 200 MICRON TFL BALL TIP SINGLE USE FIBER; Powered Laser Surgical Instrument

Model Number	TFL-FBX200BS
Medical Device Problem Codes	Material Fragmentation (1261); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic kidney stone with ureteroscopy and laser lithotripsy, the powered laser surgical instrument sparked at the plug and broke the fiber off of the base while it was inserted inside the laser system.The reported event resulted in a procedural prolongation of less than 30 minutes.There were no reports of 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.

• Brand Name: 200 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 ; +1(508)207-7661
• MDR Report Key: 50853311
• Report Number: 3011050570-2026-00924
• Device Sequence Number: 18530130
• Product Code: GEX
• UDI-Device Identifier: 00821925043985
• UDI-Public: 00821925043985
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K242191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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-FBX200BS
• Device Lot Number: KHS10666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 laser system.
• Patient Sex: Unknown