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 09/14/2023

Event Type  malfunction  

Event Description

The customer reported that the facility's tfl-pls power supply failed and then the unit began smoking.The event was found during preparation for use in an unspecified therapeutic procedure.There were no reports of patient harm.This event includes two (2) reports.Report with patient identifier (b)(6) laser system model tfl-pls , serial number (b)(6).Report with patient identifier (b)(6)-laser fiber- tfl-fbx550s, lot unknown.This report being submitted is for report with patient identifier (b)(6)-laser system model tfl-pls , serial number (b)(6).

Manufacturer Narrative

The device was not returned to olympus for evaluation and follow up with the user facility is currently being performed.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided.

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, a definitive root cause could not be established.The probable cause of the power supply failing and smoking could not be determined.The console was not returned to be serviced, attempts to contact the customer yielded no response.A physical evaluation could not be performed.Moreover, console device history reviews (dhr(s)) were reviewed and it was found that there were no discernible scrap, non-conformance reports (ncrs), or recorded process deviations related to the user request.Per soltive laser system instructions for use (ifu): "the soltive laser system is designed for maximum safety and performance.Under normal operating conditions and careful use, a maintenance check of the device is recommended by a qualified technician, every 12 months.¿ 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.; 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 ; 5082077661
• MDR Report Key: 17908386
• MDR Text Key: 325393373
• Report Number: 3003790304-2023-00393
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1