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)
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
This supplemental report is to inform that after obtaining additional information from the customer, there were only three patients involved, and this report is being retracted.The three events are recorded under the following patient identifiers: (b)(6).

• 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: 16218889
• Report Number: 3003790304-2023-00023
• Device Sequence Number: 15300927
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown