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

Model Number TFL-PLS

Device Problems Temperature Problem (3022); Explosion (4006)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not 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 soltive premium superpulsed laser system fiber exploded at the connector.The issue was found during initial activation.The laser ureteroscopy procedure completed.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to b5, d4, d10, e3, g2 for information inadvertently left out of previous report.Correction to h6 problem code.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device for this complaint was not returned and a physical inspection could not be performed.Based on the results of the investigation, this failure appears to be the result of the laser fiber breaking.No device malfunction was identified with the laser console and the console appears to have operated as expected.The console provided energy per input from the footswitch.Olympus will continue to monitor field performance for this device.

Event Description

The therapeutic laser ureteroscopy was completed using a similar replacement device.There was a delay of less than 5 minutes to replace the subject device.The related patient identifiers are as follows: (b)(6) for the soltive premium superpulsed laser system.(b)(6) for the 150 micron tfl ball tip single use fiber.

• 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: 18269078
• MDR Text Key: 329747920
• Report Number: 3011050570-2023-00212
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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: 150 MICRON SINGLE USE FIBER (LOT KR260888)