MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and it is being sent to the service center for evaluation.The device therefore is pending evaluation.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device after two minutes of operation, suddenly stopped functioning.The issue occurred during device inspection at customer¿s site.There were no further details provided regarding the event.There was no patient involvement on this report, no user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Device evaluation confirmed the reported issue.When the (h) and (s) buttons were activated, it was confirmed that the transducer was not producing any output power and both the check probe box and error box illuminated red indicating the transducer was not working properly.Review of dhr records indicate the device was manufactured and tested in accordance with all applicable procedures and all functional and electrical tests passed and final product release criteria were met at the time of manufacture.As the device is not serviceable further troubleshooting was not performed and a definitive root cause could not be determined.It was determined that likely causes of transducer failure include; fluid ingress or an internal wiring defect.A failure of the generator can be excluded as the procedure was able to be completed with a second transducer.As the device was to be returned to the customer, therefore the unit could not be destructively disassembled and a definitive root cause could determined.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10428580
• MDR Text Key: 219548952
• Report Number: 3011050570-2020-00047
• Device Sequence Number: 1
• Product Code: FEO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1