MAUDE Adverse Event Report: GYRUS ACMI, INC. 150 MICRON TFL BALL TIP SINGLE USE FIBER; LASER FIBER

Model Number TFL-FBX150BS

Device Problem Fracture (1260)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and the fiber failed testing.The distal tip had a small portion broken off and there was complete severance of the fiber in the middle of the shaft.There was no evidence of use on the fiber.The sales representative indicated that the customer broke the fiber during the return to olympus for evaluation.The device was damaged during handling.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 sales representative reported to olympus that the generator would not recognize the customer¿s fiber.The customer was able to complete the procedure with another fiber.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to b5.Please see updates to b5, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The sales representative confirmed the customer broke the fiber during the device return process.Therefore, based on the results of the investigation it¿s likely the fiber break was a result of the fiber being mis-handled during the return of the fiber to olympus.Olympus will continue to monitor field performance for this device.

Event Description

This report is being submitted for the broken fiber.

• Brand Name: 150 MICRON TFL BALL TIP SINGLE USE FIBER
• Type of Device: LASER 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: 16103311
• MDR Text Key: 308666913
• Report Number: 3003790304-2023-00005
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

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-FBX150BS
• Device Lot Number: KR206014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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