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

Model Number SPL-S

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of the device confirmed the reported issue.The unit failed probe test and had no output due to faulty receptacle.Missing legs and minor scratches on housing were observed.The device had been previously serviced by olympus, therefore a service history review will replace the device history record.This device is a loaner device and has undergone multiple inspections as an asset return.The most recent inspection was on october 26, 2020.At that time of the repair, faulty transducer receptacle and faulty wire display board to receptacle were found.Missing one leg and minor scratches on housing were observed.The repair performed on the device included replacing the transducer receptacle, display board wire jumper, and bumper.The unit passed functional test, output test and electrical safety test.Damage to the receptacle is often incurred as a result of user error, often the user does not realize all connections are push/pull and instead the plug is twisted upon connection or removal.This action results in damage to the pins internal to the socket and may crack or damage the housing.As stated in the instruction for use : connect the transducer to the generator by pressing the plug straight in.Caution do not twist or turn the plug.Connect the transducer to the generator by aligning the key way of the transducer connector with the key way slot on the transducer receptacle on the front panel.Push straight in.Caution do not twist or turn the plug.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that the device was found with no output from the generator.The user was reported to be not using a footswitch and only the buttons on the transducer.The high power indicator on the front panel illuminates when the button on the transducer is pushed however no output produced.The issue occurred during an unspecified procedure.There was no patient harm or injury reported on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: b7, g4, g7, h2, h6 and h10.Further communication with the customer conveyed the following information: the device was able to be turned on.There were no errors, warnings, alarms, alerts or warnings received.This issue was discovered during use, during the procedure.There was no patient injury, infection or medical intervention required.The procedure is percutaneous nephrolithotomy, which was therapeutic.There was a delay of about twenty minutes and the patient was under general anesthesia.The procedure was able to be completed.They had switched to a tfl-pls laser.The serial number is unknown.There are no settings on the spl-s.The device was inspected.No damage or abnormalities observed.Standard spl-pdbx376 probes.The lot number is unknown.There were no other issues with any other devices.The device will not be returned to olympus.The probes were not saved and were discarded.

• 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: 11210891
• MDR Text Key: 250463625
• Report Number: 3011050570-2021-00026
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005054
• UDI-Public: 00855279005054
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1