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

Model Number	SPL-S
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility returned the olympus asset, shockpulse-se lithotripsy system, to the olympus service center.Upon inspection and testing of the returned device, it was observed that the device had no power.This report is being submitted for the reportable malfunction found during evaluation.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned as part of the asset return process it was found that the device had no power, there was an additional finding of the housing had minor cosmetic wear and tear.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide correction to d5, h6, h10.The inspection found the device has no power due to faulty power unit.
Additional Manufacturer Narrative
"this report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.H4 was reported as (b)(6) 2014.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the was not determined as he unit successfully passed all functional tests, output tests, and electrical safety tests.Olympus will continue to monitor field performance for this device.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• 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: 18245755
• Report Number: 3011050570-2023-00204
• Device Sequence Number: 17907281
• Product Code: FEO
• UDI-Device Identifier: 00855279005016
• UDI-Public: 00855279005016
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2023

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-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 12/01/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/16/2023; 12/22/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown