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

Model Number	SPL-SR
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Communication or Transmission Problem (2896)
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 system exhibited an unspecified error during use on an unknown procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
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.In addition, the following reportable malfunctions were identified during the device evaluation: transducer socket is cracked, damaged pin in socket.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following stress of the affected parts led to the suggested phenomena; however, the cause of this stress could not be further specified.As a result of checking the instruction manual ifu/instructions for use, the following descriptions related to this event were found: drawing number and revision number of ifu: en-spl-ifur_ar_13.0.In the ifu it is stated in chapter 4.5 front panel of generator: transducer receptacle connect the transducer to the generator by pressing the plug straight in.Caution: do not twist or turn the plug.The transducer receptacle light turns from flashing green to solid green when the transducer is plugged in.The transducer receptacle light is red when the transducer is malfunctioning and should be replaced.In the ifu it is stated in chapter 2.3.2 general: 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.
Event or Problem Description
No additional information received from customer.

• 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: 23920929
• Report Number: 3011050570-2025-01510
• Device Sequence Number: 9041227
• Product Code: FEO
• UDI-Device Identifier: 00821925043824
• UDI-Public: 00821925043824
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2016
• 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