MAUDE Adverse Event Report: GYRUS ACMI, INC. 365 MICRON TFL SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number TFL-FBX365S

Device Problem Smoking (1585)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that the 365 micron tfl single use fiber smelled like smoke and had the aiming beam dim with the fiber barley breaking up the stone and the inside of the hub on the fiber burnt.The issue was found during the therapeutic ureteroscopy with stone extraction procedure.There were no reports of patient harm.Related patient identifiers are as follows: (b)(6).

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: 365 MICRON TFL SINGLE USE FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18576239
• MDR Text Key: 333709658
• Report Number: 3011050570-2024-00023
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

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-FBX365S
• Device Lot Number: KR342628
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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