MAUDE Adverse Event Report: GYRUS ACMI, LLC SHOCKPULSE; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-PDBX376
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure while the lithotripter was active the probe broke in half.

• Brand Name: SHOCKPULSE
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, LLC; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 22352631
• Report Number: 22352631
• Device Sequence Number: 8081582
• Product Code: FEO
• UDI-Device Identifier: 00821925044241
• UDI-Public: (01)00821925044241(17)290417(10)KR449942
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025
• Report Date (Section F): 06/20/2025

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-PDBX376
• Device Catalogue Number: SPL-PD376
• Device Lot Number: KR449942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• 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 Age: 41 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Date Report Sent to FDA: 06/20/2025