ShockPulse Lithotripsy Generator SPL-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00855279005054), received between Nov 4, 2020 and Sep 5, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  A USER FACILITY REPORTED TO OLYMPUS WHEN THE PEDAL ON SHOCKPULSE-SE LITHOTRIPSY SYSTEM IS PRESSED, AN ERROR MESSAGE POPS UP AND THE UNIT WILL NOT WORK. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683276 ↗
• MalfunctionJun 30, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A USER FACILITY REPORTED THAT THE SHOCKPULSE-SE LITHOTRIPSY SYSTEM STARTS WITH AN ERROR. THE EVENT OCCURRED DURING PREPARATION FOR USE. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, DAMAGED BOARDS WERE OBSERVED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14879965 ↗
• MalfunctionJan 28, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE WAS FOUND NOT PRODUCING NORMAL ENERGY , INTERFERENCE SAYING ELECTRICAL SHORT MESSAGE, NO FURTHER INFORMATION PROVIDED. NO PATIENT IMPACT OR HARM REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11246061 ↗
• MalfunctionJan 21, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH NO OUTPUT FROM THE GENERATOR. THE USER WAS REPORTED TO BE NOT USING A FOOTSWITCH AND ONLY THE BUTTONS ON THE TRANSDUCER. THE HIGH POWER INDICATOR ON THE FRONT PANEL ILLUMINATES WHEN THE BUTTON ON THE TRANSDUCER IS PUSHED HOWEVER NO OUTPUT PRODUCED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11210891 ↗
• MalfunctionJan 20, 2021Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE WAS FOUND WITH BROKEN TRANSDUCER RECEPTACLE. BENT PINS WERE FOUND INSIDE THE TRANSDUCER. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED . NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11204764 ↗
• MalfunctionJan 13, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT DURING AN ASSET RETURN INSPECTION THE DEVICE WAS OBSERVED WITH FAULTY TRANSDUCER RECEPTACLE. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11163830 ↗
• MalfunctionNov 11, 2020Output Problem; Output Problem

  UPDATED INFORMATION ON THE EVENT REPORTED. THE EVENT OCCURRED DURING A THERAPEUTIC PCNL(PERCUTANEOUS NEPHROLITHOTOMY ) PROCEDURE. NO OTHER DEVICES WERE INVOLVED IN THE EVENT OR REPLACED DURING THE COURSE OF THE PROCEDURE. THE PROCEDURE WAS DELAYED 5 MINUTES NO INFORMATION WAS PROVIDED AS TO WHETHER OR NOT THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824958 ↗
• MalfunctionNov 4, 2020Material Twisted/Bent; Output Problem; Material Twisted/Bent; Output Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE THE DEVICE WAS FOUND WITH CONNECTION ISSUES. THE PINS INSIDE THE CONNECTOR WERE FOUND BROKEN. THERE WERE NO FURTHER DETAILS PROVIDED REGARDING THE EVENT. NO PATIENT HARM OR INJURY WAS REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10784665 ↗