MAUDE Adverse Event Report: GYRUS ACMI, INC. TFL LASER FOOTSWITCH- WIRELESS; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-AFSWL
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the wireless laser footswitch was not working, was unable to be paired and presented the error 152.The event occurred during the middle of a diagnostic cysto with ureteral stone removal, that was completed with a corded foot pedal and a delay of 5 minutes with extended anesthesia.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned.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: d4, g2(company representative was inadvertently selected on the initial medwatch).Additional information added to field h4,h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.The device was not returned to olympus for inspection; therefore the reportable malfunction could not be confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The following is included in the instructions for use (ifu): soltive¿ laser system, revision ah contains the instructions to pair the wireless footswitch.Also, it states the following: "if wireless footswitch connection issues are encountered, try moving the wireless footswitch closer to the system console.If the relocation of the wireless footswitch fails to resolve the connection issue, try moving the system console and wireless footswitch away from any wlan access points.Olympus will continue to monitor field performance for this device.

• Brand Name: TFL LASER FOOTSWITCH- WIRELESS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 18816595
• Report Number: 3011050570-2024-00089
• Device Sequence Number: 8531212
• Product Code: GEX
• UDI-Device Identifier: 00821925044272
• UDI-Public: 00821925044272
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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-AFSWL
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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-PLS SUPERPULSED LASER SYSTEM SN# (B)(6)
• Patient Sex: Unknown