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

Model Number	TFL-SLS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the soltive pro superpulsed laser system would not pair with the tfl-afswl and they could not properly configure the wireless foot pedal to the system.There were no reports of patient harm.
Additional Manufacturer Narrative
In speaking with olympus technical assistance center (tac), the customer was advised to change the batteries and check to see if they were installed property.When releasing the pairing button, the customer was instructed to select continue on the screen, within 4 seconds, and try to pair the foot pedal.The customer called the tac a second time to report that when trying to pair the foot pedal, there was a message to press the middle button on the foot switch to pair, and nothing happened.The tac representative advised the customer that the foot pedal appears to be damaged and it should be replaced.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented 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 investigation, a definitive root cause of the reported wireless foot-switch pairing issue could not be determined, as the device was not returned to olympus for evaluation, however, the issue may be due to equipment interference, failure by the user to follow the pairing instructions and or an intermittent equipment component malfunction.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.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18327152
• Report Number: 3003790304-2023-00448
• Device Sequence Number: 7438451
• Product Code: GEX
• UDI-Device Identifier: 00821925044135
• UDI-Public: 00821925044135
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 11/29/2023
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TFL-SLS - SN: (B)(6).
• Patient Sex: Unknown