MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PRO SUPERPULSED LASER SYSTEM; GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM

Model Number	TFL-SLS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urethral Stenosis/Stricture (4501)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date is unknown.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An olympus representative reported to olympus, on behalf of the customer, that a patient developed urethral restriction after a stone removal procedure using the soltive pro superpulsed laser system.There was no reported issue or injury during the procedure.Additional information is being requested to determine the severity of the restriction and its impact to the patient.The customer reported this event has occurred a total of four times with four separate patients.These events are recorded under the following patient identifiers: (b)(6).
Additional Manufacturer Narrative
Updated fields: a2, a3, a4, b2, b3, b5, b7.This report is being submitted due to the additional information received that is reflected in b5.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Additional information was received from the user facility.The patient's renal function was confirmed to have been impacted by the urethral restriction.About 7.5 months after the stone removal procedure, the patient underwent a right ureteral balloon dilatation with stent placement and was later referred to another facility for a possible ureteroureterostomy.An olympus representative and the user facility also clarified that this event occurred only three times with three different patients and not four, as originally reported.These events are recorded under the following patient identifiers: (b)(6).An olympus representative and the user facility confirmed that there were only three patients affected.Hence, this report is no longer required.
Additional 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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for an evaluation, a physical inspection could not be performed.Urethral stricture is a known complication of medical procedures that involve inserting an instrument, such as an endoscope, into the urethra.The olympus device may have caused/contributed to the reported event but there is no evidence to suggest that a device malfunction occurred.Olympus will continue to monitor field performance for this device.

• Brand Name: SOLTIVE PRO SUPERPULSED LASER SYSTEM
• Common Device Name: GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM
• 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: 16218885
• Report Number: 3003790304-2023-00021
• Device Sequence Number: 7455661
• Product Code: GEX
• UDI-Device Identifier: 00821925044135
• UDI-Public: 00821925044135
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2023

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-SLS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/23/2023; 05/11/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/22/2023; 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 86 KG