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 06/08/2023

Event Type  malfunction  

Event Description

The customer reported that it started smoking when the subject device was plugged in.The reported issue was observed while preparing the subject device, prior to an unspecified procedure.There was no report of patient or user injury due to the event.

Manufacturer Narrative

The subject device is expected to be returned to olympus for further evaluation and testing.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to correct information that was provided in the initial medwatch report and to provide additional information that was received from the user facility regarding the reported issue.Correction to information provided in b3 and g3 of the initial medwatch report: the event date shouldn't have been reported.The event date is unknown.The aware date (date received by manufacturer) should have been 03oct2023.

Manufacturer Narrative

According to the customer the reported issue was observed during preparation for use for a therapeutic laser lithotripsy procedure.There was no delay, and the procedure was completed using a similar device (tfl-pls serial number (b)(6)).It was confirmed there was no patient impact as a result of the reported issue.The device was returned to olympus and the evaluation, and the reported issue was confirmed, when plugged in the device started smoking.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, root cause was identified as a power supply component failure.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: 17936002
• MDR Text Key: 325677802
• Report Number: 3003790304-2023-00400
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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