MAUDE Adverse Event Report: GYRUS ACMI, INC 200 MICRON TFL BALL TIP SINGLE USE FIBER; SOLTIVE¿ LASER SYSTEM(SOLTIVE¿LASER FIBERS, AND ACCESSORIES)

Model Number TFL-FBX200BS

Device Problem Fracture (1260)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

An olympus representative reported an out of box failure occurred as three inches of the device broke after being advanced through a semi-rigid scope.The case continued with a new fiber and same scope.There was no harm or user injury reported.

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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the probable cause of the reported issue could not be identified.Since the device was not returned for inspection, the nature of the break is unknown.Therefore, the root cause of this event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 200 MICRON TFL BALL TIP SINGLE USE FIBER
• Type of Device: SOLTIVE¿ LASER SYSTEM(SOLTIVE¿LASER FIBERS, AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 13774431
• MDR Text Key: 294804865
• Report Number: 3003790304-2022-00039
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

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: KR174666
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2021
• 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