MAUDE Adverse Event Report: Gyrus ACMI, Inc. SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB; lithotriptor, ultrasonic

Model Number	SPL-SR
Medical Device Problem Codes	Loose or Intermittent Connection (1371); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the lithotripsy system for a separate issue.During the initial evaluation of the returned device, due to poor contact of transducer socket, press the "s" button on the transducer and hold it, "standard power" light is not illuminating green was found.No patient involvement.
Additional Manufacturer Narrative
The investigation is currently ongoing.A supplemental report will be submitted upon completion of the investigation or if new and significant information becomes available.Olympus will continue to monitor the field performance of this device and evaluate any additional information received through post-market surveillance activities.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
• 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 ; +1(508)207-7661
• MDR Report Key: 50696044
• Report Number: 3011050570-2026-00881
• Device Sequence Number: 9685169
• Product Code: FEO
• UDI-Device Identifier: 00821925043824
• UDI-Public: 00821925043824
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: Other
• Device Model Number: SPL-SR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown