Single Use Mechanical Lithotriptor V BML-V232QR-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170218347), received between May 17, 2023 and Jan 4, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2024Break; Break

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING THE MIDDLE OF THE THERAPEUTIC GALLSTONE REMOVAL, THE SINGLE USE MECHANICAL LITHOTRIPTOR V BROKE AT THE SOLID PART OF THE WIRES WHERE IT CONNECTS TO THE DISPOSABLE HANDLE. AS A RESULT, IT WAS NO LONGER POSSIBLE TO MAKE PRESSURE WITH THE HANDLE TO BREAK THE BASKET. A NON-OLYMPUS EMERGENCY LITHOTRIPTER WAS THEN USED AND WHILE USING IT, THE BASKET BROKE IN THE MIDDLE OF ITS WORKING LENGTH WHICH MADE IT IMPOSSIBLE TO KEEP USING THIS LITHOTRIPTER. TO RESOLVE THE SITUATION, THE DOCTOR CARRIED OUT A HYDROSTATIC DILATATION (PAPILLA DILATATION) AND THEN A FOGARTY BALLOON AND A FORCEPS FOR THE FOREIGN MATERIAL. THE BASKET WAS RELEASED FROM THE STONES AND COULD BE REMOVED. THE PATIENT HAD VERY HEAVY BLEEDING THE LAST 10 MINUTES OF THE PROCEDURE, WHICH MADE THE DOCTOR USE A COVERED PROSTHESIS TO ENSURE DRAINAGE. THE BLEEDING MAY HAVE BEEN CAUSED BY THE MANEUVER THAT WAS PERFORMED NOT RELATED TO THE PRODUCT BREAKAGE. THE BLEEDING RESOLVED BY THE END OF THE PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE COULD NOT BE COMPLETED SUCCESSFULLY BECAUSE THE GALLSTONES COULD NOT BE REMOVED IN THE END. AFTER THE P

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18447305 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE SINGLE USE MECHANICAL LITHOTRIPTER V WAS USED TO BREAK THE GALLSTONES, HOWEVER THE DEVICE HANDLE WAS SPINNING AND UNABLE TO BREAK THE STONES. THE DEVICE HANDLE WAS ROTATED WHILE THE TUBE SHEATH WAS EXTENDED FROM THE COIL SHEATH DURING USE. THE WIRE WAS BROKEN AS AN EMERGENCY RESPONSE. AS A RESULT, THE PROCEDURE WAS COMPLETED BY FORCIBLY CRUSHING THE STONES USING A NON-OLYMPUS DEVICE. THE PROCEDURE WAS PROLONGED BY ABOUT 15 MINUTES BUT NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO ADDITIONAL DIAGNOSTIC OR MEDICAL INTERVENTIONS WERE UNDERTAKEN. PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR COMPLICATIONS AND PATIENT'S CURRENT CONDITION/OUTCOME WAS REPORTED AS "NO PROBLEMS" IDENTIFIED. THERE WERE NO HEALTH HAZARDS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034956 ↗
• InjuryMay 17, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, TWO SINGLE USE MECHANICAL LITHOTRIPTOR WERE BROKEN. A DORMIAN TRAPEZOIDAL BASKET WAS PLACED ON THE DEPOSIT AND A MECHANICAL LITHOTRIPSY ATTEMPT WAS MADE, DURING WHICH THE LITHOTRIPTER BROKE IN THE HANDLE AREA. A RESCUE LITHOTRIPSY ATTEMPT WAS MADE WITH THE SOEHENDA LITHOTRIPTOR, DURING WHICH THE CAGE CABLE BROKE AND THE CAGE BECAME TRAPPED ON THE DEPOSIT. ANOTHER ATTEMPT AT LITHOTRIPSY USING A MECHANICAL LITHOTRIPTOR WAS MADE AND ANOTHER BREAKAGE OF THE LITHOTRIPTOR NEAR THE HANDLE OCCURRED. SUBSEQUENT ATTEMPTS AT LITHOTRIPSY USING A TRAPEZOIDAL CAGE RESULTED IN FRAGMENTATION OF THE DEPOSIT, REMOVAL OF THE FRAGMENTS AND RELEASE OF THE TRAPPED CAGE. DUE TO THE PROLONGED PROCEDURE AND THE UNCERTAINTY OF COMPLETE REMOVAL OF THE FRAGMENTS OF THE DEPOSIT, A PLASTIC PROSTHESIS WITH A DIAMETER OF 10FR WAS INSERTED, ACHIEVING EFFECTIVE BILE DRAINAGE. EXPOSURE TIME WAS REPORTED AS 1 HOUR AND 6 MINUTES. THE PATIENT'S VITAL SIGNS AND CLINICAL CONDITION WERE MONITORED AND PLANNED REPLACEMENT OF THE PROSTHESIS OR ITS REMOVAL IN 3 MONTHS. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950699 ↗