MAUDE Adverse Event Report: GYRUS ACMI, INC SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM; SOLTIVE LASER SYSTEM

Model Number	TFL-PLS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device passed the inspection tests output, but the top display is loose.The cause of the reported adverse event cannot be conclusively determined at this time.
Event or Problem Description
This is 3 of 3 reports.The physician reported that the patient¿s left kidney failed after undergoing a laser lithotripsy using the subject device.There was no device problem observed during the procedure and no apparent patient injury noted during the procedure.During the procedure, the physician noted two kidney stones measuring 2mm and 6mm.The intended procedure was completed using the same device, and the patient was discharged from the physician¿s clinic with pain medication.Four to six weeks the patient returned for a follow up visit.During the visit an x-ray was performed to check the surgery site, and the physician noted a stone like object in the surgery site, which is measuring about 15mm x 10mm in size.As a result the patient was reexamined using a flexible ureteroscope (model/serial number unknown) and a ct-scan was later performed as well.The ct-scan confirmed that the patient¿s ureter had a calcified tissue, and the physician described it like a thermal damage, which likely made one of the patient¿s kidney to fail.However, dr.(b)(6) stated that the patient did not report any pain, the calcified tissue in the ureter was confirmed only through imaging.The patient is reportedly doing well.The patient¿s stent was removed from the patient on (b)(6) 2020.Cross reference related mfr.Report numbers: 3003790304-2020-00115 and 3003790304-2020-00116.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional based on the legal manufacturer's investigation.The root cause was unable to be determined.A clinical investigation was performed and the clinical investigation concluded that these events were potentially attributed to user technique or handling.Olympus will continue to monitor the field performance of this device.

• Brand Name: SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM
• Common Device Name: SOLTIVE LASER SYSTEM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10782150
• Report Number: 3003790304-2020-00127
• Device Sequence Number: 3312854
• Product Code: GEX
• Combination Product (Y/N): N
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFL-PLS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 50