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

Model Number SPL-S

Device Problems Break (1069); Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection of the device found a broken power board (l2) and unit needs to be upgraded.Minor scratches on the housing were observed.The identified parts were replaced, unit was upgraded.Once completed, the device was tested and passed all required testing and specifications.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 Description

During a demo asset return inspection the device was found with broken power board.There was no patient involvement on this event reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.This unit was manufactured early 2015.Dhr records were not made available to olympus for review, likely due to age of the unit.For this reason, a final manufacture date is not available.The device has been previously serviced by olympus therefore a service history review will replace dhr review.This device has undergone multiple inspections as being asset returns since june 2018.All service records indicate that the device was returned to manufacturer specification.The most recent inspection was completed on 18may2020 (ds# 20068555), and there were no problems found.The unit passed all functional and leakage current tests, all output powers were within specification.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.".

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11262920
• MDR Text Key: 250461472
• Report Number: 3011050570-2021-00040
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925044197
• UDI-Public: 00821925044197
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SPL-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/21/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1