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

Model Number	SPL-SR
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.Upon evaluation of the device, there was a water/solution leakage to the device.In addition, damaged boards due to corrosion was noted.The unit required a change of a power board, control board, and power switch.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A user facility reported that the shockpulse-se lithotripsy system starts with an error.The event occurred during preparation for use.During a standard service inspection of the customer returned device, damaged boards were observed.This report is to capture the reportable malfunction found at inspection.There was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 damaged circuit board was likely due to user mishandling or spills.The event can be prevented by following the instructions for use which state: - "to minimize the risk of electric shock and generator damage, keep all liquids away from the generator.If liquid is spilled into this product, immediately stop the procedure and contact olympus.If the power cord gets wet, fully dry it before use.Otherwise the user may receive an electric shock." - "wipe generator cabinet, front panel, power cord and footswitch with a sponge (or towel) lightly moistened with a mild soap solution (use medical-grade, low foaming and neutral ph detergent).Follow with a sponge (or towel) lightly moistened with clear warm (42 ¿ 52 °c [107 ¿ 125 °f]) tap water." 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; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14879965
• Report Number: 8010047-2022-11129
• Device Sequence Number: 6215935
• Product Code: FEO
• UDI-Device Identifier: 00855279005054
• UDI-Public: 00855279005054
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2018
• 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