Lithotripsy Transducer ShockPulse-SE SPL-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00855279005023), received between Jan 21, 2021 and Nov 8, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 8, 2025Class IIOpen, Classified

   The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

   Z-0452-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Energy Output Problem; Energy Output Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED NO OUTPUT, WHICH FAILED THE PROBE TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642650 ↗
• MalfunctionJun 21, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED AN ERROR CODE DISPLAYED WHEN PLUGGED INTO THE TRANSDUCER DURING SET UP. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE FOR A LITHOTRIPSY PROCEDURE TO BREAK DOWN KIDNEY STONES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580232 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THE SHOCK PULSE LITHOTRIPSY TRANSDUCER HAD A BROKEN TRANSMITTER. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233168 ↗
• MalfunctionApr 26, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THE LITHOTRIPSY TRANSDUCER SUCTION ADJUSTMENT KNOB WAS STUCK. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195869 ↗
• MalfunctionApr 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THERE WAS FLUID LEAKING FROM A HOLE ON THE SUCTION CONTROL RING OF THE LITHOTRIPSY TRANSDUCER. THE EVENT OCCURRED DURING A THERAPEUTIC PERCUTANEOUS NEPHROLITHOTRIPSY. THE PROCEDURE WAS DELAYED IN THE MIDDLE OF THE PROCEDURE TO OBTAIN ANOTHER SIMILAR DEVICE IN ORDER TO CONTINUE TO COMPLETION OF THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167718 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT THE SHOCKPULSE LITHOTRIPSY TRANSDUCER DURING A THERAPEUTIC PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE THERE WAS A PHYSICAL DEFECT OF THE CONNECTING PIECE, AND THE END WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THE DEVICE SUCTION PORT END WAS BROKEN. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010896 ↗
• MalfunctionSep 26, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT HIS OLYMPUS SHOCKPULSE LITHOTRIPSY TRANSDUCER HAD A LEAK UPON OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817463 ↗
• MalfunctionSep 26, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS SHOCKPULSE LITHOTRIPSY TRANSDUCER ULTRASOUND WAS NOT WORKING DURING PROCEDURE PREPARATION. ACCORDING TO THE INITIAL REPORTER ANOTHER LASER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817362 ↗
• MalfunctionApr 13, 2023Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE WAS NOT WORKING, THE ERROR LIGHT ON THE DEVICE WAS HIGHLIGHTED. THE ISSUE WAS FOUND DURING A PERCUTANEOUS NEPHRECTOMY PROCEDURE (THERAPEUTIC). THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS A DELAY OF APPROXIMATELY TWENTY (20) MINUTES IN THE PROCEDURE, HOWEVER, PER THE REPORT, THERE WAS NO PATIENT HARM OR ADVERSE EVENT OCCURRED DUE TO THE DELAY. NO HARM WAS REPORTED, NO PATIENT INJURY, NO USER INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16729792 ↗
• MalfunctionNov 1, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS WHILE PREPARING FOR USE, A TRANSDUCER ERROR CODE AND OTHER ERROR MESSAGES DISPLAYED WHEN THE SHOCKPULSE LITHOTRIPSY TRANSDUCER WAS PLUGGED IN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709725 ↗
• MalfunctionOct 19, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  AN OLYMPUS REP REPORTED ON BEHALF OF THE CUSTOMER, THE SHOCKPULSE LITHOTRIPSY TRANSDUCER DISPLAYED AN ERROR CODE. BOTH THE ERROR LIGHT AND PROBE CHECK LIGHT WERE LIT. THE EVENT OCCURRED IN THE MIDDLE OF A THERAPEUTIC LEFT COMPLEX PERCUTANEOUS NEPHROLITHOTOMY. THE PROCEDURE WAS DELAYED WHILE THE USER FACILITY TRIED TROUBLESHOOTING WITHOUT SUCCESS; AND HAD TO BE COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633929 ↗
• MalfunctionAug 10, 2022Break; Break

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR USE, THE SUCTION CONNECTOR ON THE SUBJECT DEVICE WAS FOUND TO BE DAMAGED. THE DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, SERVICE FOUND THE TIP OF THE SUCTION PORT WAS BROKEN AND DAMAGED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BROKEN SUCTION PORT). THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200081 ↗
• MalfunctionJun 10, 2022Break; Break

  A USER FACILITY RETURNED THE OLYMPUS ASSET SHOCKPULSE LITHOTRIPSY TRANSDUCER, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE SUCTION PORT WAS BROKEN OFF. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653361 ↗
• MalfunctionMay 27, 2022Break; Break

  THE OLYMPUS ASSET DEVICE, SHOCKPULSE LITHOTRIPSY TRANSDUCER, WAS SENT TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS DISCOVERED THE SUCTION PORT HAD BROKEN OFF. THERE WAS NOT PATIENT INVOLVEMENT. THE MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION OF THE SUCTION PORT BROKEN OFF FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522785 ↗
• MalfunctionFeb 3, 2022Defective Device; Output Problem; Defective Device; Output Problem

  THE CUSTOMER REPORTED TRANSDUCER ERROR CODE . DEFECTIVE - ERROR ON THE SCREEN. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447297 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT "THE DEVICE BLEW OFF THE TIP DURING THE ONGOING SURGICAL APPLICATION. TIP FOR SUCTION DEVICE INTRAOPERATIVELY BROKEN OFF." THERE WAS NO PATIENT INJURY OR INFECTION REPORTED. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387746 ↗
• MalfunctionSep 17, 2021Break; Defective Component; Break; Defective Component

  DURING AN ASSET RETURN INSPECTION THE DEVICE WAS FOUND WITH DAMAGED SUCTION PORT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492572 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE SUCTION PORT WAS BROKEN. THE ISSUE FOUND DURING AN ASSET RETURN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215308 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PLASTIC TIP OF THE DEVICE IS BROKEN. THE ISSUE FOUND DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147249 ↗
• MalfunctionJun 16, 2021Break; Break

  THIS IS AN ASSET RETURN WHICH WAS FOUND TO HAVE A BROKEN SUCTION PORT DURING ESTIMATION. THERE WAS NO DEVICE ISSUE OR PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008955 ↗
• MalfunctionApr 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED, THE SHOCKPULSE LITHOTRIPSY TRANSDUCER WAS NOT RECOGNIZED BY THE GENERATOR. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS BROKEN ON THE END AND WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701419 ↗
• MalfunctionJan 29, 2021Fracture; Fracture

  AS REPORTED, THE SECTION OF THE SHOCKPULSE LITHOTRIPSY TRANSDUCER THAT ATTACHES TO THE MONITOR WAS NOTED TO BE BROKEN DURING DEVICE MAINTENANCE. THERE WAS NOT REPORTED PATIENT INVOLVEMENT FROM THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 11252123 ↗
• MalfunctionJan 28, 2021Break; Break

  THE SERVICE CENTER WAS INFORMED DURING PREPARATION FOR USE, THERE WAS A PROBLEM WITH THE PROBE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11247405 ↗
• MalfunctionJan 21, 2021Power Problem; Power Problem

  AS REPORTED, THE POWER CORD ON THE SHOCKPULSE LITHOTRIPSY TRANSDUCER HAS A BROKEN CONSOLE CONNECTOR. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11210626 ↗