MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PRO SUPERPULSED LASER SYSTEM; SOLTIVE LASER SYSTEM

Model Number	TFL-SLS
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the laser system had broke at the connector flexible part and sparked.The issue was found during the therapeutic urethroscopy with laser lithotripsy procedure which was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d9, should have been marked yes only.The device was not returned to olympus for physical evaluation.The device was evaluated onsite by an olympus field service engineer.The customer's reportable malfunction was not reproduced.The device was within performance specifications.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause for the event could not be determined as the event was not confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: SOLTIVE PRO SUPERPULSED LASER SYSTEM
• Common Device Name: SOLTIVE LASER SYSTEM
• 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: 18812568
• Report Number: 3011050570-2024-00087
• Device Sequence Number: 4325067
• Product Code: GEX
• UDI-Device Identifier: 00821925044135
• UDI-Public: 00821925044135
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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-SLS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown