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

Model Number SPL-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Sepsis (2067); Unspecified Respiratory Problem (4464)

Event Type  Injury  

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.The following adverse events occurred during or after a pcnl procedure using a shock-pulse-se lithotripter: one-clavien dindo grade iva complication: respiratory insufficiency requiring re-intubation and 72-hour icu stay.Four-clavien dindo grade i-complications: requiring extended hospitalization: sepsis , bleeding , respiratory,and organ complication.Additional information was requested from the authoring physician, at this time no further information has been provided.Case with patient identifier (b)(6) reports device malfunctions described in this article.

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.

Manufacturer Narrative

This report is being updated to provide investigation findings.No device was available for evaluation.The device history record (dhr) review cannot be performed because no specific device lot/serial number was reported.A risk assessment was conducted and no action was indicated at this time.The instructions for use (ifu) shipped with the device provided the user with the following information related to the reported event(s): "the shockpulse-se lithotripsy system is intended to be used for fragmentation of urinary tract calculi in the kidney, ureter, and bladder." (intended use, page 7); "this medical device should be operated only by or under the direct supervision of a physician experienced in ultrasonic lithotripsy procedures." (warnings and cautions, page 7); "on the basis of the patient¿s general condition, the doctor in charge must decide whether the planned use is possible or not." (health risks, page 3); "proper care and maintenance are critical for safe and effective operation of the shockpulse-se system.We recommend careful inspection of all equipment upon receipt and prior to each use as a safeguard against possible injury to patient or operator." (page 6).Conclusion: the definitive cause of the user's experience could not be determined.Olympus will continue to monitor complaints for this device through regular trending activities and take action if indicated.

• 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: 13028434
• MDR Text Key: 286498204
• Report Number: 3003790304-2021-00195
• 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: 02/01/2022

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?: Yes
• Is this a Product Problem Report?: No
• 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: 01/05/2022
• 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
• Patient Outcome(s): Other; Hospitalization; Required Intervention