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

Model Number SPL-T

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The loaned asset unit was returned to the service center for evaluation.The unit was inspected / tested and the evaluation found the suction port was damaged.There were no other functional problems found.The root cause of the reported event could not be determined at this time as the investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that during a standard inspection of the shockpulse lithotripsy transducer, the suction port was found damaged.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide a summary of the investigation results.The original equipment manufacturer (osta) performed a device history record review and no abnormalities were noted.This device was manufactured (cybersonics inc.) in march 2018.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined that the damage to the suction port may be a result of use beyond validated lifespan and/or improper reprocessing.The device ifu notes the transducer is validated for 100 reuses and outlines approved cleaning and sterilization methods.Olympus will continue to monitor complaints for this device.It is unknown how the unit has been reprocessed or if it remains within its validated lifespan.Olympus will continue to monitor complaints for 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: 10384852
• MDR Text Key: 219549227
• Report Number: 3011050570-2020-00036
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• 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: 07/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1