MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-PR340
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal end of the rock crusher lithotripsy probe was damaged and corroded.The issue occurred during preparation for use for a therapeutic shock wave lithotripsy procedure and was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The device was not returned to olympus for inspection.A root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction is being made to previously submitted d3 - lot #, to ni.
Event or Problem Description
The lot number reported in d4 was found to be invalid and is being corrected to ni.

• Brand Name: SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• 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: 20343658
• Report Number: 3011050570-2024-10371
• Device Sequence Number: 15423781
• Product Code: FEO
• UDI-Device Identifier: 00821925043800
• UDI-Public: 00821925043800
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPL-PR340
• Device Lot Number: SA888598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown