MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-PLS
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation/inspection.Based on the results of the investigation, the system error 10 was identified.It is likely the result of component failure of the emergency stop button.; however, 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
The customer returned the superpulsed laser system to the service center for a separate issue.During the device analysis, the field service engineer (fse), indicates that a system error 10 was found.It was determined that the emergency stop button needed to be replaced.There was no patient involvement.

• Brand Name: SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM
• 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: 25408837
• Report Number: 3011050570-2026-00619
• Device Sequence Number: 10311647
• Product Code: GEX
• UDI-Device Identifier: 00821925044111
• UDI-Public: 00821925044111
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: Other
• Device Model Number: TFL-PLS
• Device Lot Number: MDUF240044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown