MAUDE Adverse Event Report: GYRUS ACMI, INC. TFL LASER FOOTSWITCH- WIRELESS; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-AFSWL
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 wired tfl laser footswitch doesn't pair with laser unit.The issue occurred during set up / inspection for use (during set up in room / before patient in room).There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to a previously submitted report.The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.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 to a previously submitted report and the final investigation results.Corrected fields: b5, d9.The device was returned to olympus for inspection, and the reported failure was confirmed determined to be caused by low battery voltage.The device was visually and functionally tested.The footswitch was equipped with two alkaline procell constant aa batteries, each measuring 1.4 vdc, which is below the nominal rating of 1.5 v.Due to the low battery voltage, two new energizer alkaline batteries (1.5 v each) were installed.After replacement, the footswitch was re tested and paired successfully with the soltive laser system.Based on the results of the investigation, it is likely the following led to the malfunction: component failure due to stress of repeated use, external factors, or handling.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
It was reported the wireless laser footswitch doesn't pair with laser unit.The issue was observed during preparation for use.There was no report of patient harm.

• Brand Name: TFL LASER FOOTSWITCH- WIRELESS
• 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: 23942993
• Report Number: 3011050570-2026-00003
• Device Sequence Number: 7830197
• Product Code: GEX
• UDI-Device Identifier: 00821925044272
• UDI-Public: 00821925044272
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2026

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-AFSWL
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 03/02/2026; 05/20/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/04/2026; 03/10/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown