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

Model Number SPL-T

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the reported issue was confirmed.The handpiece was found faulty, transducer did not function.As the device is a non-serviceable item, a definitive root cause cannot be determined.The device was returned unrepaired.Review of dhr records indicates the device met all final release criteria and passed all functional tests at the time of manufacture.This suggests the reported failure is use related.Leakage, and consequent electrical failure may be the result of improper reprocessing or use beyond its validated lifetime.As stated on the ifu and as a preventive measure, the user manual states: the device is validated for 100 reuses, must be cleaned, and sterilized according to listed instruction.It is unknown how many use cycles or which reprocessing methods had been used by the customer.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that the device was found leaking and was not working.No further details provided regarding the reported event.No patient involvement on this report.No user injury reported.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 10678948
• MDR Text Key: 211509699
• Report Number: 3011050570-2020-00105
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 0855279005023
• UDI-Public: (01)0855279005023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2020

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-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1