MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number TFL-PLS

Device Problem Smoking (1585)

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

Event Date 12/08/2023

Event Type  malfunction  

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.

Event Description

The customer reported to olympus, the olympus powered laser surgical instrument was not turning on.The customer heard a pop and the device started smoking from the exhaust fan and would not turn on.The issue was found during preparation for use for an unknown procedure.There was no report of patient injury or medical intervention associated with this event.Related patient identifiers:(b)(6) (single use laser fiber).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, a non-reportable phenomenon such as a damaged front panel was identified.The reported event was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 months since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to a faulty power supply olympus will continue to monitor field performance for this device.

• Brand Name: SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM
• 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: 18436774
• MDR Text Key: 331810383
• Report Number: 3011050570-2024-00006
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00821925044111
• UDI-Public: 00821925044111
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFL-PLS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 550 MICRON TFL SINGLE USE FIBER.