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

Model Number	TFL-AFSW
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the new wired-laser footswitch when connecting to the soltive device, immediately displayed the foot switch error.The issue occurred during reprocessing.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation the right pedal of the footswitch intermittently connected without any pressure applied.The footswitch was disconnected and reconnected multiple times, consistently replicating the issue and confirming the user¿s request.A visual inspection revealed numerous scratches and a small dent on the connector.The device was returned to the original equipment manufacturer, and the footswitch was plugged into a known good system.The test results indicated that the connector was physically damaged and difficult to plug into the system.Upon connection, the system immediately displayed a 151 error, preventing further testing.Olympus will continue to monitor field performance for this device.

• Brand Name: TFL LASER FOOTSWITCH- WIRED
• 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: 19381020
• Report Number: 3011050570-2024-00202
• Device Sequence Number: 7688486
• Product Code: GEX
• UDI-Device Identifier: 00821925044258
• UDI-Public: 00821925044258
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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-AFSW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: UNSPECIFIED SOLTIVE SYSTEM
• Patient Sex: Unknown