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

Model Number	TFL-SLS
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An olympus field service engineer had a service call at the customer site.After troubleshooting the issue, and replacing the batteries in the foot switch, the foot switch paired successfully.The device was not returned.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 had a foot pedal that was not pairing and connecting.There were no reports of patient harm.
Event or Problem Description
The event occurred while preparing for a therapeutic lithotripsy procedure.The procedure and patient anesthesia were prolonged by 5-10 minutes to switch out the footswitch.This happened right at the beginning of the case.The procedure was completed.No medical intervention required.No other devices were replaced during the case.No patient impact and outcome of the procedure was not affected.The device was inspected prior to use.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field b5, h4 and h6.Corrected fields: d8 (should be blank).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over three (3) years since the subject device was manufactured.Since the subject device was not returned to legal manufacturer, the reported event could not be confirmed neither the condition of the device.Based on the results of the investigation from the information obtained, sales representative called in stating that after replacing the batteries in the foot switch, the foot switch paired successfully.There was no detailed description of the cause, and since the device did not return, further information could not be obtained.As a result, the definitive root cause was unable to be determined since replacing the batteries resolved the issue.Therefore, no problem was identified with the device itself.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: 18889120
• Report Number: 3011050570-2024-00099
• Device Sequence Number: 7539707
• Product Code: GEX
• UDI-Device Identifier: 00821925044135
• UDI-Public: 00821925044135
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 02/26/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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