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

Model Number	TFL-SLS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the soltive pro superpulsed laser system's hand piece laser fiber caught fire.The issue occurred during an unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being submitted to provide additional information based on the legal manufacturer¿s final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the device investigation, a definitive root cause of the reported hand piece ¿ laser fiber catching fire issue could not be determined, as the device was not returned to olympus for evaluation.Olympus will continue to monitor field performance for this device.

• Brand Name: SOLTIVE PRO SUPERPULSED LASER SYSTEM
• Common Device Name: SOLTIVE PRO SUPERPULSED 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: 19974267
• Report Number: 3011050570-2024-00326
• Device Sequence Number: 18233435
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2021
• 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