MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PRO SUPERPULSED LASER SYSTEM; GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM

Model Number	TFL-SLS
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Technical assistance center (tac) support engineer communication with the olympus rep.Noted that the "sales rep replaced the batteries in the tfl-sls wireless footswitch and the low battery message still displayed on the tfl-sls , confirmed that with the new batteries, the wireless footswitch paired to the tfl-sls.The rep.Used second set of batteries however, the wireless footswitch would not pair with the laser system stated that the wireless footswitch will need to be replaced.Follow up is in progress regarding the event reported.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Olympus representative (rep.) reported after replacing the batteries in the tfl-sls wireless footswitch, the low battery message still displayed on the tfl-sls.The rep.Was trying to pair up the wireless footswitch with the laser system.No harm was reported.No patient harm, no user injury reported.This event includes two reports: report with patient identifier (b)(6) (wireless footswitch model tfl-afswl with unknown serial number).Report with patient identifier (b)(6) ( laser system tfl-sls, serial no.(b)(4)) this report is being submitted for report with patient identifier (b)(6) ( laser system tfl-sls, serial no.(b)(4)).
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.It has been over 3 years since the subject device was manufactured.The device was not returned for evaluation.Based on the results of the investigation, the definitive root cause of the low battery message could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SOLTIVE PRO SUPERPULSED LASER SYSTEM
• Common Device Name: GENERAL/MULTIPLE SURGICAL SOLID-STATE 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: 16370279
• Report Number: 3003790304-2023-00070
• Device Sequence Number: 15296230
• Product Code: GEX
• UDI-Device Identifier: 00821925044135
• UDI-Public: 00821925044135
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2019
• 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-AFSWL.WIRELESS FOOTSWITCH.
• Patient Sex: Unknown