MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB); LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-SR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the lithotriptor, ultrasonic receptacles socket burnt.There were no reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: this event was caused by a component failure of transducer receptacle.The cause of the transducer receptacle malfunction could not be determined.The instructions for use states the following in relation to the suggested phenomenon: 2 warnings and cautions 2.3 health hazards 2.3.2 general 2.Perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance.Thoroughly inspect all electrical cables and probes before each use.Do not use if there is any evidence of deterioration.Replace if any damage or excessive wear is observed.Inspect the transducer plug pins, cord, and transducer body for mechanical damage (bent pins, cracks, etc.).After each use or prior to cleaning and sterilizing, carefully inspect the transducer and cable for tears, cracks, or other signs of damage.Do not use a shockpulse-se system that fails to meet the criteria stated in the labeling or that has been damaged.Otherwise, injury to the patient, personnel and/or an adverse effect on the procedure could result.Olympus will continue to monitor field performance for this device.

• 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 ; 5082077661
• MDR Report Key: 23692695
• Report Number: 3011050570-2025-01384
• Device Sequence Number: 9071887
• Product Code: FEO
• UDI-Device Identifier: 00821925043824
• UDI-Public: 00821925043824
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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-SR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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