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

Model Number	SPL-T
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During onsite inspection of the lithotripsy, it was found transducer plug is not secured.There was no patient involvement.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The investigation is still ongoing.A supplemental report will be submitted when the investigation has been completed or when new and significant information becomes available.¿ olympus will continue to monitor the field performance of 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: 50847416
• Report Number: 3011050570-2026-00923
• Device Sequence Number: 15827002
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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-T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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