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

Model Number SPL-SR

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device transducer receptor malfunctioned.The issue found during incoming inspection.According to the reporter, the device when press switch on transducer handling ,¿high mode/standard mode¿ had switched.There was no patient involvement on this report, no user harm or injury reported due to the event.

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.Please see updated sections: d4,d10,g4, g7, h2, h3,h4, h6 and h10.The device was evaluated by olympus thailand.The user report was confirmed.It was found that transducer receptacle damage resulted in the reported phenomenon.Device history records were reviewed and showed the product met all specifications upon release.Damage to the transducer 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.

• 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: 10501483
• MDR Text Key: 206822077
• Report Number: 3011050570-2020-00066
• 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: 01/21/2021

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-SR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1