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

Model Number TFL-FBX200S

Device Problem Fracture (1260)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

The customer reported to olympus that the soltive laser had an error message saying the laser did recognize the fiber during preparation for use.The customer tried a second fiber and experienced another error 405 code.The customer could not get the laser to stop the error after a reset.There were no reports of patient harm associated with this event.The subject device was sent to olympus for evaluation.During inspection and testing, a break was found in the fiber.This report is being submitted for the malfunction found during evaluation (broken fiber).

Manufacturer Narrative

The device was returned to olympus in a sealed, post-market pouch and inspected.The fiber had two kinks along the fiber body as well as a full fiber break.The distal tip appeared unused and there were no visual defects relating to the proximal handle.The complaint is likely the result of mis-handling of the fiber after the device did not work or as the result of rough handling of the fiber during shipping.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.

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 device for this complaint was returned to olympus broken and no damage had been reported by the customer.The damage is visually obvious and would have been reported by the customer if it had been received in that condition or if it had been broken by the customer.For this reason, it is likely the fiber break has been determined to be due to mishandling of the fiber during the return trip.Olympus will continue to monitor field performance for this device.

• Brand Name: 200 MICRON TFL SINGLE USE FIBER
• Type of Device: LASER 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 01581-4003 ; 5082077661
• MDR Report Key: 16086390
• MDR Text Key: 308589515
• Report Number: 3003790304-2023-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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-FBX200S
• Device Lot Number: KR222851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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