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

Model Number SPL-SR

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Evaluation determined that the device was found with damaged with a burnt transducer receptacle.The transducer was connected and activated immediately without pressing any activation button.The output power was found low however, it was audible, and device was found switched to error mode.The transducer plug needs to be replaced.The device was placed for repair.Based on the evaluation findings, the reported issue was confirmed.The reported failure was due to damaged, burnt transducer attributed to component failure.

Event Description

It was reported that the device transducers were not recognized.No further details were provided regarding the event.There was no patient involvement on this reported event.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr), review of dhr records indicates the unit met all final release criteria prior to release.This includes passing extensive visual inspection and functional and electrical safety testing at the time of manufacturer.This suggests manufacturing did not contribute to the reported failure.It was reported that the device transducers were not recognized.Evaluation of the returned device confirmed the complaint.The failure was attributed to a damaged transducer receptacle which was observed to be "burnt".As stated in the device ifu (instruction for use) it instructs the user to inspect the equipment for damage prior to use."make sure that the following shockpulse-se system equipment is present for the procedure.The operator should ensure that the generator and all cables and all components on transducer are undamaged prior to beginning any procedure." 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: 10398808
• MDR Text Key: 203146991
• Report Number: 3011050570-2020-00039
• 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: 09/02/2020

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: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1