MAUDE Adverse Event Report: GYRUS ACMI, INC. 550 MICRON TFL SINGLE USE FIBER

Model Number	TFL-FBX550S
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device experienced excessive flash/damage on two of the fibers while using the soltive laser system.The user was able to complete the unspecified procedure using a third fiber.There were no reports of patient or user harm.Report 1 of 3.This inquiry was cloned from inquiry (inq-144546/original) because multiple devices were reported.This inquiry (inq-145210/cloned) captures device 2 of 2.Auj/08-jan-2025.Per ur-350558 this is the correct event description: (b)(4), sales rep, called to report the following phenomenon.User reported to (b)(4) coworker who reported to (b)(4) of that they experience excessive flashes on two of the fibers.They were able to complete the procedure using a third fiber.They have one unused from this box that they want to return.I created the sfdc case to capture the reported phenomenon and conference the sales rep.In with (b)(4) of urology sales support for additional assistance.(b)(4) reported that the facility's policy dictates that they cannot released the failed fiber to him.Rma number (b)(4).Fg 495722/(b)(6) 2025.
Additional Manufacturer Narrative
Related patient identifier: (b)(6).The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: 550 MICRON TFL SINGLE USE FIBER
• Common Device Name: 550 MICRON TFL SINGLE USE FIBER
• 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: 22208569
• Report Number: 3011050570-2025-00606
• Device Sequence Number: 7723190
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2025

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-FBX550S
• Device Lot Number: KR465922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 06/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFL-PLS SOLTIVE PREM LASER SYSTEM SN#UNK.
• Patient Sex: Unknown