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

Model Number	SPL-S
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device had been previously serviced by olympus.This device is a loaner unit and has undergone multiple inspections upon being returned as an asset.In the most recent inspection , during that inspection, minor scratches on the housing and missing legs were observed.However, the unit successfully passed all functional tests, output tests, and electrical safety tests.The device was returned as part of the asset return process.During evaluation, the unit did not power on due to faulty power supply.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.This unit was produced in january 2015.Based on the results of the investigation, it is likely that the following led to the malfunction: given that the user did not report any problems and the damage was discovered during the device inspection, it is likely that the issue occurred during transit, possibly due to improper handling such as a dropped package.The shockpulse ifu addresses this: "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." olympus will continue to monitor the field performance of this device.
Event or Problem Description
The shockpulse-se lithotripsy system was returned as part of the asset return process.During routine inspection of the device by olympus, a defective power supply was found.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Common Device Name: LITHOTRIPSY
• 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: 17368709
• Report Number: 3011050570-2023-00086
• Device Sequence Number: 17887119
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: 06/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/21/2023
• 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