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

Model Number	TFL-AFSWL
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the wireless footswitch could not be paired to the generator.It was not specified during what type of device usage the reported event initially occurred.There was no report of patient injury or medical intervention associated with this event.
Additional Manufacturer Narrative
The event evaluation is ongoing.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.Information added to the fields: d8, h6.Correction in the fields: e1, e2, e3.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned to olympus for inspection; therefore, the customer's reportable malfunction could not be confirmed.While speaking with the olympus technical assistance center (tac), on the phone the customer was able to resolve the issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the foot switch error (e37) occurred due to the user was pressing the foot pedal at the incorrect time which resulted in some confusion.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.Olympus will continue to monitor field performance for this device.
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 was not possible to determine the manufacture date of the device, as the serial number was unable to be obtained.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the result of a use error.The e37 code states to "please release the foot pedal".It is possible that the user was pressing the foot pedal at the incorrect time which resulted in some confusion.This issue was resolved via contact with the user facility.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: 19707480
• Report Number: 3011050570-2024-00258
• Device Sequence Number: 20766836
• Product Code: GEX
• UDI-Device Identifier: 00821925044272
• UDI-Public: 00821925044272
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 09/24/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown