Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 11.3 Fr (3.76mm) X 396mm SPL-PD376Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00855279005030), received between Jun 4, 2018 and Feb 24, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2022Flaked; Flaked

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AS THE THERAPEUTIC PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE WAS NEARING THE END, TINY SILVER SPECKS WERE NOTED TO BE FLOATING IN THE PATIENT. THE SPECKS WERE CLEARLY VISIBLE ON THE SCREEN AND ALL WERE SUCTIONED OUT OF THE PATIENT. THE DOCTOR FELT THAT THE SPECKS HAD COME OFF THE DEVICE TIP AS THERE WAS A POSSIBLE SMALL BLACKENED AREA AT THE TIP VISIBLE ON THE SCREEN. HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AND THE TIP EXAMINED, THERE WAS NOTHING VISIBLE TO THE NAKED EYE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO DELAY IN THE COMPLETION OF THE PROCEDURE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592729 ↗
• MalfunctionJan 13, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THE CUSTOMER REPORTED TO OLYMPUS, THERE WERE THREE SMALL HOLES IN THE PACKAGING OF THE SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX. THIS WAS OBSERVED PRIOR TO A THERAPEUTIC PERCUTANEOUS NEPHROLITHOTOMY (LITHOTRIPSY OF A KIDNEY STONE). THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13246388 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE PROBE BROKE IN HALF DURING A PERCUTANEOUS NOVEL LITHOTRIPSY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE LOT NUMBER OF THE DEVICE USED WAS NOT PROVIDED. NO KNOWN DEVICE FRAGMENTS FELL INTO THE PATIENT. NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11158286 ↗
• MalfunctionNov 27, 2018Material Integrity Problem; Material Integrity Problem

  SHOCKPULSE LITHOTRIPSY PROBE BROKE INSIDE THE PATIENT. BROKEN PIECE IS RETRIEVED FROM THE PATIENT. NO INJURY OR HEALTH HAZARD WAS REPORTED TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8106152 ↗
• MalfunctionSep 14, 2018Material Integrity Problem; Material Integrity Problem

  THE USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE THE LITHOTRIPSY PROBE BROKE OFF SIX INCHES FROM THE SEATING THREAD. AN EXTRA HOLE WAS MADE IN AN ATTEMPT TO LOCATE THE BROKEN PIECE.

  Patient problems: No Code Available

  MAUDE report 7876514 ↗
• MalfunctionJun 4, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  "SPL-PD376 STERILE PACKAGING WAS OPEN UPON OPENING OUTER BOX. NO PATIENT INVOLVEMENT."

  Patient problems: No Patient Involvement

  MAUDE report 7564805 ↗