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

Model Number	SPL-S
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was inspected.The l2 of the power board was found broken.Minor scratches, chips on the housing was observed.The identified parts were replaced and device was repaired.Once completed the device was tested and passed all required testing and specifications.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that during an asset return inspection the device was found with a broken power board.No patient involvement on this event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.This device was manufactured by cybersonics inc in january 2015.Partial dhr records were provided to olympus for review.Partial records do not include packaging or labeling operations for this reason a final manufacture date not available.The device had been previously serviced by olympus therefore a service history review will replace dhr review.This device has undergone multiple inspections as being asset returns.This device was previously inspected by olympus on october 13, 2020 (ds# (b)(4)).At that time, minor scratches and dings on the housing were observed.The unit passed functional test, output test and electrical safety test.Since the user did not report any problems and the damage was found during device inspection, it is likely the problem happened during transit due to improper handling such as dropped package.The device ifu states "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage," (page 1).

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11143019
• Report Number: 3011050570-2021-00009
• Device Sequence Number: 19368117
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1