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

Model Number	TFL-FBX550S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
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 550 micron tfl single use fiber was broken.There were no reports of patient harm.
Event or Problem Description
The issue occurred during a diagnostic cystoscopy procedure with laser litho for bladder stones.There was a delay of 1 minute and the procedure was completed using similar device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields: b5, d8, d9, h3, h4, h6 and h8.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.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is likely that the event was caused by the user not following the instructions in the instruction for use.The customer clamped the fiber which resulted in damage to the glass fiber and ultimately the fiber breaking.The instructions for use (ifu) warns the prevention method associated with the event in page 1 of the soltive fiber ifu which states "do not clamp the fiber with a hemostat or other instruments." 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: 19929676
• Report Number: 3011050570-2024-00321
• Device Sequence Number: 16828367
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 09/30/2024

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: KR260892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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