MAUDE Adverse Event Report: GYRUS ACMI, INC. 200 MICRON TFL BALL TIP SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number TFL-FBX200BS

Device Problems Fracture (1260); Flare or Flash (2942)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the fiber was broken at the strain relief section of the fiber near the proximal handle.There is discoloration and evidence of melting at the end of the strain relief.The broken end appears to have been a rough break with possible signs of burning/ discoloration on the non-connector break side.The evidence suggests the fiber break was present upon the initial firing of the laser.Based on the results of the investigation, the most likely cause for the issue was due to user-handling.The exact user-handling issue cannot be identified.The fiber likely broke at the strain relief point due to a force exerted on the strain relief point resulting in a fiber break which resulted in energy escaping the fiber and igniting the coating.A device history review revealed no issues that could have caused or contributed to the reported issue.This report is related to mfr 00401 (1/2) olympus will continue to monitor the field performance of this device.

Event Description

It was reported the ball tip single use fiber cracked and a flame was present at the laser port on the laser system.The procedure was completed with a similar device.There were no reports of patient harm.

• Brand Name: 200 MICRON TFL BALL TIP SINGLE USE FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): 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: 18708067
• MDR Text Key: 336304846
• Report Number: 3003790304-2024-00018
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2024

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
• Device Operator: Health Professional
• Device Model Number: TFL-FBX200BS
• Device Lot Number: KR337688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TFL-PLS.