MAUDE Adverse Event Report: GYRUS ACMI, INC. 150 MICRON TFL SINGLE USE FIBER

Model Number	TFL-FBX150S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During evaluation, a break was found near the middle of the fiber body.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported error 447 occurred with the single-use fiber.The subject device was sent to olympus for evaluation.During evaluation, a break was found near the middle of the fiber body.This report is being submitted for the malfunction found during evaluation (fiber break).There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information added to b3 and b5.
Event or Problem Description
The following requested information was received from the customer regarding the event: the event (error 447) occurred during a therapeutic procedure.The procedure was completed using a similar device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to d4, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause for this complaint failure is due to mis-handling of the fiber during the return to olympus.No fiber damage was reported from the customer site and thus it¿s likely the fiber broke at some point between being re-packaged by the customer and being received at olympus.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: 150 MICRON TFL SINGLE USE FIBER
• Common Device Name: SINGLE USE FIBER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15275987
• Report Number: 3003790304-2022-00159
• Device Sequence Number: 17893091
• Product Code: GEX
• UDI-Device Identifier: 00821925043879
• UDI-Public: (01)00821925043879(17)231222(10)KR178566
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/18/2023

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-FBX150S
• Device Lot Number: KR178566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 03/21/2023
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/15/2022; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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