MAUDE Adverse Event Report: GYRUS ACMI, INC. 200 MICRON TFL BALL TIP SINGLE USE FIBER

Model Number TFL-FBX200BS

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

This device was received and inspected on the same day.The device was received in a sealed, post-market pouch and was confirmed to be a tfl-fbx200bs fiber with a lot number of kr262855.The fiber has been broken off at the strain relief and the entire length of the fiber body is separate from the proximal handle.The separated portion of the fiber body does not have any other visual defects and the distal tip is intact and appears unused.The proximal handle appears to be in good repair with the proximal cap on.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 Description

The customer reported to olympus that the laser fiber was not working properly.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing the following was found: the fiber was broken off at the strain relief and the entire length of the fiber body is separate from the proximal handle.This report is being submitted for the malfunction found during evaluation (fiber break).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to 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 that the reportable phenomenon occurred due to mishandling by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: 200 MICRON TFL BALL TIP SINGLE USE FIBER
• Type of Device: FIBER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581 4003
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581 4003
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581-4003 ; 5082077661
• MDR Report Key: 16243876
• MDR Text Key: 309154249
• Report Number: 3003790304-2023-00031
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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
• Device Operator: Health Professional
• Device Model Number: TFL-FBX200BS
• Device Lot Number: KR262855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1