MAUDE Adverse Event Report: Gyrus ACMI, Inc. SHOCKPULSE LITHOTRIPSY TRANSDUCER.; lithotriptor, ultrasonic

Model Number	SPL-T
Medical Device Problem Codes	Failure to Deliver Energy (1211); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the lithotripsy was not producing ultrasonic energy.The issue occurred during percutaneous nephrolithotomy (pcnl) therapeutic procedure.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure was not confirmed.A root cause could not be identified.A device history record review was completed, and no issues were identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• 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: 50752282
• Report Number: 3011050570-2026-00900
• Device Sequence Number: 9224431
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown