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

Model Number	TFL-FBX550S
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the 550 micron tfl single use fiber caught on fire.The issue occurred during an unspecified therapeutic procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the reported event was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to mishandling by the user.The event can be detected/prevented by following the instructions for use which state: do not bend or coil the soltive laser fibers beyond the recommended minimum bend radius (table 2); doing so may result in light leakage or fiber breakage that could cause personal injury if the laser is fired (refer to the laser system manual) (section-device handling).Page 3.Care must be taken to avoid exceeding the minimum bend radius of fibers.Always check the laser aiming beam at the tip of the fiber before delivering high energies or damage to the endoscope may result.Page 3.Keep the distal tip of the fiber as clean as possible during use to prevent overheating and damage.If removal is necessary to clean accumulated debris, carefully wipe along the fiber length, using a soft cloth following decontamination protocols.Be careful to not use too much force, as this can damage the fiber or laser system connector.(section-intraoperative).Page 4.Failure of the structural integrity of the device or the failure of the device may lead to treatment room personnel or patient injury, and/or fire in the treatment room.(section-warning): 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: 18728221
• Report Number: 3011050570-2024-00074
• Device Sequence Number: 17539689
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/23/2024

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: KR223565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 02/17/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown