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	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus; therefore, the reported event could not be confirmed.Due to no known serial number, the footswitch device history record could not be retrieved.If information permitting the retrieval of the dhr becomes available at a later date, the investigation shall be updated appropriately.Based on the results of the investigation, the root cause of the event was unable to be identified.This report is related to mfr 00404 (2/2) olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that a left ureteroscopy, biopsy and laser ablation of ureteric tumor procedure was being performed.The customer wanted to use the thulium laser to ablate the tumor but the foot pedal is wirelessly connected to the thulium laser machine.The foot pedal would not connect to the machine so the thulium laser could not be used.The customer tried switching off bluetooth from phones as this happened previously, but this did not work.The customer had to use another device instead to complete the procedure.There were no reports of harm.

• 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: 18707778
• Report Number: 3011050570-2024-00062
• Device Sequence Number: 7271098
• Product Code: GEX
• UDI-Device Identifier: 00821925044272
• UDI-Public: 00821925044272
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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: 09/22/2023
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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