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

Model Number	TFL-FBX365S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation where service confirmed the customer's complaint.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 fiber likely broke on the ridge of the scope.This can be categorized as mis-handling of the fiber and a user error.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that the fiber broke about a foot from the distal end of the fiber.The reported problem was found during preparation for a therapeutic cystolitholapaxy.The part of the fiber breakage point was inside the scope and it didn't break in the patient's bladder.There was no harm or user injury reported due to the event.

• Brand Name: 365 MICRON TFL SINGLE USE FIBER
• Common Device Name: 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: 15320749
• Report Number: 3003790304-2022-00184
• Device Sequence Number: 12138883
• Product Code: GEX
• UDI-Device Identifier: 00821925044005
• UDI-Public: (01)00821925044005(17)230604(10)KR962678
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: KR962678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/30/2022
• Date Device Manufactured: 06/04/2020
• 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