MAUDE Adverse Event Report: GYRUS ACMI, INC. 550 MICRON TFL SINGLE USE FIBER

Model Number TFL-FBX550S

Device Problem Fracture (1260)

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

Event Date 01/25/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the 550 micron tfl single use fiber presented a "damaged fiber" error.The issue was found during procedure.The procedure was completed using a similar device.Inspection and testing of the returned device found the distal tip of the device was missing and appeared to have broken off with some evidence of tearing/ damage of the coating near the end where the tip should be.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customers allegation was confirmed.The device evaluation found the distal tip of the device was missing and appeared to have broken off with some evidence of tearing/damage of the coating near the end where the tip should be.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 definitive root cause of the broken distal tip and peeled coating could not be determined.It is possible that the fiber damage was caused by the broken distal tip, which may have been caused by user mishandling.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "if the fiber tip is visibly damaged or requires excessive amounts of energy to affect coagulation or vaporization, discontinue use and replace with a new fiber for optimum results.Alternately, strip and cleave the fiber as outlined in fiber cleaving and stripping instructions on page 5." olympus will continue to monitor field performance for this device.

• Brand Name: 550 MICRON TFL SINGLE USE FIBER
• Type of Device: 550 MICRON TFL SINGLE USE FIBER
• 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: 16572773
• MDR Text Key: 311584400
• Report Number: 3003790304-2023-00123
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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-FBX550S
• Device Lot Number: KR223563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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