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

Model Number SPL-SR

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation at service center site in i(b)(6).Evaluation of device confirmed the reported issue.The device power board found physical damage during evaluation.One capacitor found broken and some other components were bent.The root cause of the issue was found to be attributed to electronic component failure.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device was found with a damaged motor inside.The issue occurred during a receipt inspection.There was no patient involvement on this report.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device history record (dhr) review and the review of the instructions for use (ifu).A review of the dhr found no anomalies or abnormalities identified during device production.To ensure proper function of the device the ifu recommends the following preventative maintenance: "the operator should ensure the probes, generator, transducer, and accessories are undamaged prior to beginning any procedure.Take special care to ensure all cables are undamaged.Olympus recommends that the generator and transducer are returned every 24 months for a calibration and safety inspection.To return a unit for calibration and safety inspection, contact olympus customer service and request a return material authorization (rma) number." as no abnormalities were noted during dhr review, damage to the internal circuit board is likely a result of rough handling or has been incurred during transportation through out the life of this device.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10672840
• MDR Text Key: 220153248
• Report Number: 3011050570-2020-00103
• 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: 12/10/2020

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-SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1