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

Model Number SPL-S

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled ¿multi-institutional prospective randomized control of novel intracorporeal lithotripters: shockpulse-se vs trilogy trial¿ patients experienced adverse events during or after percutaneous nephrolithotripsy (pcnl) procedures using the shockpulse-se.Study aim: evaluate the efficiency of two novel lithotripters: trilogy and shockpulse-se.Method: prospective multi-institutional randomized trial comparing outcomes of percutaneous pcnl using two novel lithotripters between february 2019 and june 2020.The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications.Conclusion: both the trilogy and shockpulse-se lithotripters are highly efficient at removing large renal stones.In this study, we noted differences between the two devices including fewer device malfunctions when trilogy device was utilized.Device malfunction reported: 15 instances of suction failure.Additional information was requested from the authoring physician, at this time no further information has been provided.Case with patient identifier (b)(6) reports adverse events described in this article.

Manufacturer Narrative

"this report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record could not be performed as no serial number was provided and device was not returned.Based on the results of the investigation, regarding the suction function of the shockpulse-se lithotripsy system (spl-s), the device ifu (instructions for use) states, "the shockpulse-se system does not have any means to automatically regulate suction pressure because every case has different requirements.Suction control can be adjusted manually from no suction to full suction by rotating the suction ring to allow for adequate visualization while the surgeon locates the stones.It is recommended to start with a vacuum pressure of 150 mmhg while the probe is active to maximize stone removal efficiency and allow adequate cooling of the probe and the transducer."; and "if the aspiration becomes interrupted, first ensure that the suction tubing is not kinked or clogged, that the suction control is rotated fully counter clockwise when viewed from the rear (follow indicator), and then, if necessary, use the cleaning stylet to unclog the transducer and probe." a definitive root cause could not be identified.Olympus will continue to monitor field performance for this device.".

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 13028433
• MDR Text Key: 290459795
• Report Number: 3003790304-2021-00194
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925044197
• UDI-Public: 00821925044197
• 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: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1