MAUDE Adverse Event Report: UNITED SERVICE SOLUTIONS, LLC PIEZOLITH 3000 TRIPLE FOCUS LITHOTRIPTER

Model Number	P3000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
After notification of this incident, the maintenance records for the machine were reviewed.On november 11, 2024, the machine received its regularly scheduled preventative maintenance where no mechanical issues were noted.The patient was the third of eight treatments that day.Five treatments were performed after the patient's treatment using the same machine with no known complications.Since the patient's treatment, there have been 188 treatments performed on this machine with no known complications.An investigation into this event is underway.It is unclear whether the event is related to the device.A supplemental mdr will be submitted as needed as the investigation evolves.
Event or Problem Description
On (b)(6) 2025, we were notified that the patient passed away after having an extracorporeal shockwave lithotripsy treatment using the piezolith 3000 triple focus machine.The patient was treated on (b)(6) 2024 and passed away on (b)(6) 2024.An investigation into this event is underway.It is unclear whether the event is related to the device.A supplemental mdr will be submitted as needed as the investigation evolves.
Additional Manufacturer Narrative
The healthcare professional submitting the report provided additional information and communicated that based on the user facility's ((b)(6)) investigation and inquiry into the patient event there was no concern with the function or the use of the device, and there was no belief that the device contributed to the patient's death.
Event or Problem Description
(b)(6) report notes that the patient had a diagnosis of right renal stones.Right extracorporeal shock wave lithotripsy was performed on (b)(6) 2024.No complications during procedure noted.The reporting healthcare professional did not report any device malfunctions or complications during the procedure.The day after the procedure involving the device, the patient was discharged to home with his daughter with written and verbal discharge instructions.

• Brand Name: PIEZOLITH 3000 TRIPLE FOCUS LITHOTRIPTER
• Common Device Name: LITHOTRIPTER
• Manufacturer (Section D): UNITED SERVICE SOLUTIONS, LLC; 1700 west park drive; suite 410; westborough MA 01581
• Manufacturer (Section G): UNITED SERVICE SOLUTIONS, LLC; 1700 west park drive; suite 410; westborough MA 01581
• Manufacturer Contact: nikki erlenbach ; 1700 west park drive; ste 410; westborough, MA 01581 ; 5085706565
• MDR Report Key: 21437755
• Report Number: 3003300201-2025-00002
• Device Sequence Number: 14580946
• Product Code: LNS
• UDI-Device Identifier: 00810000980567
• UDI-Public: (01)00810000980567(11)180801
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: P3000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2018
• 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: Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White