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

Model Number SPL-T

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the olympus service center for evaluation.The evaluation confirmed there was no output from the device during activation; both high and standard buttons.It was determined to be a faulty transducer.Leaking was not confirmed.The transducer is non-serviceable.The root cause of the reported event cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus was informed that the shock pulse lithotripsy transducer was not working, and also leaking.No patient injury, or harm was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-00094.The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported malfunction but with no results.Based on the investigation, leakage, and consequent electrical failure may be the result of improper reprocessing or use beyond its validated lifetime.Per the device instructions for use, the device is validated for 100 reuses and 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 the field performance of 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: 10630429
• MDR Text Key: 219183139
• Report Number: 3011050570-2020-00094
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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: No Information
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1