MAUDE Adverse Event Report: GYRUS ACMI, INC 365 MICRON TFL SINGLE USE FIBER

Model Number	TFL-FBX365S
Medical Device Problem Codes	Break (1069); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer sales representative reported during an unspecified procedure, as the users were firing the laser, the fiber connection to the plastic piece came off and the laser kept on firing even though the users were not firing.The laser did not stop until the users unplugged the fiber.According to the reporter, the laser itself was working, customer tried a new fiber and worked without any issues.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue is unknown at this time.In a follow up communication, the customer reported device is being shipped for evaluation.To date, the subject device has not yet been received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to e3, h3 and h4.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, it is likely to have been related to device mishandling near the connector end/ strain relief.The distal tip shows signs of usage but the break at the connector shows no signs of use suggesting the fiber either broke after the fiber was unplugged or that the user report of the device continuing to fire is inaccurate and more likely the fiber continued to burn at the tip following ending of fiber activation.Olympus will continue to monitor field performance for this device.

• Brand Name: 365 MICRON TFL SINGLE USE FIBER
• Common Device Name: MICRON TFL 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: 15516126
• Report Number: 3003790304-2022-00257
• Device Sequence Number: 20358504
• Product Code: GEX
• UDI-Device Identifier: 00821925044401
• UDI-Public: 00821925044401
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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-FBX365S
• Device Lot Number: KR192564
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LASER SYSTEM UNIT GENERATORUNKNOWN MODEL
• Patient Sex: Unknown