Lithotripsy System ShockPulse-SE SPL-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00855279005016), received between Jan 8, 2021 and Sep 16, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THE SUBJECT DEVICE STOPPED READING ALL TRANSDUCERS, MAKING IT INOPERABLE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230458 ↗
• MalfunctionAug 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE HAD ERRORS THAT WERE COMING UP WHEN THE HAND PIECES WERE ACTIVATED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951977 ↗
• MalfunctionDec 1, 2023Power Problem; Power Problem

  A USER FACILITY RETURNED THE OLYMPUS ASSET, SHOCKPULSE-SE LITHOTRIPSY SYSTEM, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE HAD NO POWER. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245755 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED TO OLYMPUS THAT DURING AN UNKNOWN PROCEDURE, WHEN USING SHOCKPULSE-SE LITHOTRIPSY SYSTEM A VISIBLE DAMAGE TO THE CONNECTOR PIN WAS DETECTED AND AN ERROR MESSAGE WAS PRODUCED ON THE SCOPE. THE TRANSDUCER RECEPTACLE WAS REPLACED AS DAMAGED PIN WAS FOUND INSIDE THE CONNECTOR CAUSING A PROCEDURAL DELAY OF 45 MINUTES AND PATIENT ADDITIONALLY SEDATED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR VENDOR DEVICE AND NO MEDICAL INTERVENTION WAS UNDERTAKEN. NO HEALTH HAZARDS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452690 ↗
• MalfunctionJul 21, 2023Failure to Power Up; Failure to Power Up

  THE SHOCKPULSE-SE LITHOTRIPSY SYSTEM WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, A DEFECTIVE POWER SUPPLY WAS FOUND. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368709 ↗
• MalfunctionJan 13, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE WAS FOUND WITH DAMAGED TRANSDUCER RECEPTACLE. THE TRANSDUCER WAS NOT RECOGNIZED BY THE GENERATOR. NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11163682 ↗
• MalfunctionJan 8, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT DURING AN ASSET RETURN INSPECTION THE DEVICE WAS FOUND WITH A BROKEN POWER BOARD. NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11143019 ↗