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

Model Number	TFL-FBX550S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the laser fiber broke in half.The issue occurred during preparation for use before an unspecified procedure.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h3, h4, h6.It has been less than one (1) year since the subject device was manufactured.The device was returned to olympus for inspection and the customer's complaint/reportable malfunction was confirmed.Based on the results of the investigation a specific root cause cannot be determined.However, it appears to have been mishandling by the user.Fiber broken 3 feet from connector.Fiber was fired, 0 uses remaining, black burn back present on tefzel.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: the ifu pn0014679_af page.3, states that: "do not bend or coil the soltive laser fibers beyond the recommended minimum bend radius; doing so may result in light leakage or fiber breakage that could cause personal injury if the laser is fired." olympus will continue to monitor the field performance for this device.

• Brand Name: 550 MICRON TFL SINGLE USE FIBER
• Common Device Name: LASER FIBERS
• 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: 19679992
• Report Number: 3011050570-2024-00251
• Device Sequence Number: 20546015
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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-FBX550S
• Device Lot Number: KR403629
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown