Single Use Mechanical Lithotriptor V BML-V232QR-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170218361), received between Mar 29, 2022 and Jul 30, 2026 — classified as 2 deaths, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Break

  It was reported that during a therapeutic Endoscopic Retrograde Cholangiopancreatography while removing a stone, the basket cable broke in the proximal area. The doctor used the emergency Lithotriptor handle an attempt to remove the single use mechanical Lithotriptor and the cable broke again, this time in the distal area, next to the basket, leaving the stone and the basket inside the patient. As such the procedure was delayed for equal to or greater then 30 minutes under sedation, completed with a competitors device. No reports of patient harm.

  Patient problems: Foreign Body In Patient

  MAUDE report 50090758 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTOR V HAD A FAULT OCCUR WHILST INSIDE PATIENT. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395839 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " ORLANDO PROTOCOL FOR SINGLE SESSION DUCTAL CLEARANCE OF COMMON BILE DUCT STONES AT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ". OBJECTIVES: APPROACH TO MANAGEMENT OF COMMON BILE DUCT STONES (CBDS) BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS NOT STANDARDIZED. WE EXAMINED OUTCOMES BY APPLYING PREDETERMINED PROTOCOL FOR CBDS MANAGEMENT. METHODS: WHEN STANDARD EXTRACTION TECHNIQUES FAILED AT ERCP, PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT RATIO WERE CALCULATED. LARGE BALLOON SPHINCTEROPLASTY (LBS) AND/OR MECHANICAL/SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY WAS PERFORMED BASED ON PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT MISMATCH. PRIMARY OUTCOME WAS SINGLE-SESSION DUCTAL CLEARANCE. SECONDARY OUTCOME WAS ADVERSE EVENTS. RESULTS: OF (B)(4) PATIENTS TREATED OVER 16 MONTHS, (B)(4) ((B)(4)) HAD NO TAPERED BILE DUCT OR STONE-DUCT MISMATCH, AND SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED USING STANDARD TECHNIQUES IN (B)(4) OVER MEDIAN DURATION OF 14 MIN (INTERQUARTILE RANGE [IQR] 9-21 MIN). OF (B)(4) PATIENTS WITH DIFFICULT CBDS, TAPERED DUCT WAS SEEN IN (B)(4) AND/OR STONE-DUCT MISMATCH IN (B)(4)). SINGLE-

  Patient problems: Abdominal Pain; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Pneumonia; Septic Shock

  MAUDE report 20347777 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " ORLANDO PROTOCOL FOR SINGLE SESSION DUCTAL CLEARANCE OF COMMON BILE DUCT STONES AT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ". OBJECTIVES: APPROACH TO MANAGEMENT OF COMMON BILE DUCT STONES (CBDS) BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS NOT STANDARDIZED. WE EXAMINED OUTCOMES BY APPLYING PREDETERMINED PROTOCOL FOR CBDS MANAGEMENT. METHODS: WHEN STANDARD EXTRACTION TECHNIQUES FAILED AT ERCP, PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT RATIO WERE CALCULATED. LARGE BALLOON SPHINCTEROPLASTY (LBS) AND/OR MECHANICAL/SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY WAS PERFORMED BASED ON PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT MISMATCH. PRIMARY OUTCOME WAS SINGLE-SESSION DUCTAL CLEARANCE. SECONDARY OUTCOME WAS ADVERSE EVENTS. RESULTS: OF 409 PATIENTS TREATED OVER 16 MONTHS, 321 (78.5%) HAD NO TAPERED BILE DUCT OR STONE-DUCT MISMATCH, AND SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED USING STANDARD TECHNIQUES IN 99.7% OVER MEDIAN DURATION OF 14 MIN (INTERQUARTILE RANGE [IQR] 9-21 MIN). OF 88 (21.5%) PATIENTS WITH DIFFICULT CBDS, TAPERED DUCT WAS SEEN IN 79 (89.8%) AND/OR STONE-DUCT MISMATCH IN 36 (40.9%). SING

  Patient problems: Abdominal Pain; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Pneumonia; Septic Shock

  MAUDE report 20347685 ↗
• DeathOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " ORLANDO PROTOCOL FOR SINGLE SESSION DUCTAL CLEARANCE OF COMMON BILE DUCT STONES AT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ". OBJECTIVES: APPROACH TO MANAGEMENT OF COMMON BILE DUCT STONES (CBDS) BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS NOT STANDARDIZED. WE EXAMINED OUTCOMES BY APPLYING PREDETERMINED PROTOCOL FOR CBDS MANAGEMENT. METHODS: WHEN STANDARD EXTRACTION TECHNIQUES FAILED AT ERCP, PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT RATIO WERE CALCULATED. LARGE BALLOON SPHINCTEROPLASTY (LBS) AND/OR MECHANICAL/SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY WAS PERFORMED BASED ON PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT MISMATCH. PRIMARY OUTCOME WAS SINGLE-SESSION DUCTAL CLEARANCE. SECONDARY OUTCOME WAS ADVERSE EVENTS. RESULTS: OF 409 PATIENTS TREATED OVER 16 MONTHS, 321 (78.5%) HAD NO TAPERED BILE DUCT OR STONE-DUCT MISMATCH, AND SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED USING STANDARD TECHNIQUES IN 99.7% OVER MEDIAN DURATION OF 14 MIN (INTERQUARTILE RANGE [IQR] 9-21 MIN). OF 88 (21.5%) PATIENTS WITH DIFFICULT CBDS, TAPERED DUCT WAS SEEN IN 79 (89.8%) AND/OR STONE-DUCT MISMATCH IN 36 (40.9%). SING

  Patient problems: Abdominal Pain; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Pneumonia; Septic Shock

  MAUDE report 20345820 ↗
• DeathOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " ORLANDO PROTOCOL FOR SINGLE SESSION DUCTAL CLEARANCE OF COMMON BILE DUCT STONES AT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ". OBJECTIVES: APPROACH TO MANAGEMENT OF COMMON BILE DUCT STONES (CBDS) BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS NOT STANDARDIZED. WE EXAMINED OUTCOMES BY APPLYING PREDETERMINED PROTOCOL FOR CBDS MANAGEMENT. METHODS: WHEN STANDARD EXTRACTION TECHNIQUES FAILED AT ERCP, PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT RATIO WERE CALCULATED. LARGE BALLOON SPHINCTEROPLASTY (LBS) AND/OR MECHANICAL/SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY WAS PERFORMED BASED ON PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT MISMATCH. PRIMARY OUTCOME WAS SINGLE-SESSION DUCTAL CLEARANCE. SECONDARY OUTCOME WAS ADVERSE EVENTS. RESULTS: OF 409 PATIENTS TREATED OVER 16 MONTHS, 321 (78.5%) HAD NO TAPERED BILE DUCT OR STONE-DUCT MISMATCH, AND SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED USING STANDARD TECHNIQUES IN 99.7% OVER MEDIAN DURATION OF 14 MIN (INTERQUARTILE RANGE [IQR] 9-21 MIN). OF 88 (21.5%) PATIENTS WITH DIFFICULT CBDS, TAPERED DUCT WAS SEEN IN 79 (89.8%) AND/OR STONE-DUCT MISMATCH IN 36 (40.9%). SING

  Patient problems: Abdominal Pain; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Pneumonia; Septic Shock

  MAUDE report 20345801 ↗
• InjuryMay 16, 2024Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT AT THE END OF THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY ERCP PROCEDURE IN A 80 YEAR OLD, CAUCASIAN, FEMALE PATIENT, THE LITHOTRIPTOR HANDLE BROKE DUE OF THE SIZE (30MM STONE) AND HARDNESS OF THE STONE IN COMMON BILE DUCT. THE PROCEDURE WAS UNABLE TO BE COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL IN THE OPERATING ROOM WHEREIN A EMERGENCY SURGICAL PROCEDURE WAS CONDUCTED AND THE STONE WAS ABLE TO BE REMOVED. THE PROCEDURE TURNED OUT WELL ACCORDING TO THE PHYSICIAN. REPORTEDLY, THE STONE WAS A BILIARY STONE. THE PART OF THE LITHOTRIPTOR HANDLE THAT BROKE WAS CRANKED ON THE HANDLE. THE STONE WAS TOO STRONG, WHEN THE USER PUT THE RATCHET ON AND WENT TO CRANK, NO TENSION WAS CREATED. THIS INDICATES THE BASKET WAS STILL TIGHTENING AROUND THE STONE TO CRUSH IT. THE STONE WAS ABLE TO BE REMOVED SURGICALLY. FOLLOW-UP INFORMATION RECEIVED THAT THE PATIENT MADE A FULL RECOVERY WITH NO ADVERSE EFFECTS OR COMPLICATIONS REPORTED. NO PRE-EXISTING CONDITIONS REPORTED. THE PATIENT WAS DISCHARGED. THE REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331550 ↗
• InjuryMay 16, 2024Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT AT THE END OF THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY ERCP PROCEDURE IN A 80 YEAR OLD, CAUCASIAN, FEMALE PATIENT, THE LITHOTRIPTOR HANDLE BROKE DUE OF THE SIZE (30MM STONE) AND HARDNESS OF THE STONE IN COMMON BILE DUCT. THE PROCEDURE WAS UNABLE TO BE COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL IN THE OPERATING ROOM WHEREIN A EMERGENCY SURGICAL PROCEDURE WAS CONDUCTED AND THE STONE WAS ABLE TO BE REMOVED. THE PROCEDURE TURNED OUT WELL ACCORDING TO THE PHYSICIAN. REPORTEDLY, THE STONE WAS A BILIARY STONE. THE PART OF THE LITHOTRIPTOR HANDLE THAT BROKE WAS CRANKED ON THE HANDLE. THE STONE WAS TOO STRONG, WHEN THE USER PUT THE RATCHET ON AND WENT TO CRANK, NO TENSION WAS CREATED. THIS INDICATES THE BASKET WAS STILL TIGHTENING AROUND THE STONE TO CRUSH IT. THE STONE WAS ABLE TO BE REMOVED SURGICALLY. FOLLOW-UP INFORMATION RECEIVED THAT THE PATIENT MADE A FULL RECOVERY WITH NO ADVERSE EFFECTS OR COMPLICATIONS REPORTED. NO PRE-EXISTING CONDITIONS REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331533 ↗
• 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 "SOEHENDRA" 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950669 ↗
• MalfunctionAug 18, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED, DURING A LITHOTRIPSY, IT WAS NOT POSSIBLE TO FULLY RETRACT THE SHEATH INTO THE ARMOR AND THIS MADE IT IMPOSSIBLE TO CRUSH THE GALLSTONES. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248898 ↗
• InjuryAug 18, 2022Break; Break

  THE CUSTOMER REPORTED, DURING LITHOTRIPSY, THE MAIN STEEL CORD (NOT THE BASKET) WAS BROKEN. DUE TO THE SITUATION, THE EQUIPMENT COULD NOT BE REMOVED AND THE PATIENT UNDERWENT LAPAROTOMY. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15248888 ↗
• MalfunctionMar 29, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC BILE DUCT STONE REMOVAL PROCEDURE, WHEN ATTEMPTING TO CRUSH THE STONES USING THE SUBJECT DEVICE (MECHANICAL LITHOTRIPTER), THE STONES WERE HARD, THE OPERATION PIPE WAS DAMAGED, AND THE STONES BECAME STUCK. THE INTENDED PROCEDURE WAS COMPLETED AFTER SUCCESSFULLY CRUSHING THE STONES USING ANOTHER DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941022 ↗