Single Use Mechanical Lithotriptor V BML-V242QR-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04953170218392), received between Aug 9, 2018 and Aug 6, 2025 — classified as 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE METAL COIL SHEATH WAS PUSHED ON THE PLASTIC SHEATH OF THE SUBJECT DEVICE TO CRUSH THE STONE BUT BECAME STUCK AND COULD NOT PUSH THE COIL SHEATH ANYMORE. THE PLASTIC TUBE BECAME COMPRESSED, AND THE SHAPE CHANGED. 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 22728547 ↗
• MalfunctionMay 8, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989773 ↗
• InjuryMar 26, 2025Break; Break

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700325 ↗
• InjuryMar 26, 2025Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE WIRE OF THE SINGLE USE MECHANICAL LITHOTRIPTOR BROKE WHILE THE BASKET WIRE WAS INSIDE THE PATIENT WITH A STONE IN IT. TROUBLESHOOTING WAS ATTEMPTED WITH A USE OF A DIFFERENT MECHANICAL LITHOTRIPTOR BUT THE WIRE BROKE AGAIN. THE PHYSICIAN USED OTHER MEANS TO REMOVE THE BASKET WIRE BY CUTTING TWO OF THE FOUR BASKET WIRES USING AN ARGON PLASMA COAGULATION AND THEN WAS ABLE TO RELEASE THE STONE. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR AT LEAST AN HOUR. THE PROCEDURE WAS THEN COMPLETED WITH A SIMILAR DEVICE. THE PHYSICIAN STATED THERE WERE NO COMPLICATIONS BUT THE STONE WAS UNABLE TO BE CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700226 ↗
• InjuryMay 2, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE LITHOTRIPTOR BECAME STUCK INSIDE THE SCOPE. THE ISSUE OCCURRED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE ENTIRE SCOPE WAS REMOVED, AND THE WIRES WERE CUT AND RETRIEVED. THE PROCEDURE WAS THEN COMPLETED AFTER REPLACING IT WITH ANOTHER ONE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228354 ↗
• InjuryMar 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC, RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CASE, THE SINGLE USE MECHANICAL LITHOTRIPTOR, WAS USED TO GRASP THE STONE AND THE COIL SHEATH WAS CRUSHED AND DEFORMED. AS SUCH, THE STONE COULD NOT BE DESTROYED. THEREFORE, NON-OLYMPUS DEVICE WAS USED TO INCARCERATE AND BREAK THE STONE. THE WIRE WAS REMOVED, AND A TUBE STENT WAS INSERTED, AND PROCEDURE WAS COMPLETED. THERE WAS NO HEALTH HAZARD TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862009 ↗
• InjuryAug 22, 2023Break; Mechanical Problem; Break; Mechanical Problem

  THIS SUPPLEMENTAL REPORT IS BEING CREATED TO INCLUDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. WHEN THE ORIGINAL DEVICE WAS CONNECTED, NO PRESSURE WAS BEING APPLIED TO THE STONE AND THE HANDLE RETRACTED ALL THE WAY OUT AND THEN CONTINUED SPINNING. THE HANDLE WAS REATTACHED WITH THE SAME RESULT LEADING THE DEVICE TO FAIL, THEREFORE THE RESCUE DEVICE WAS APPLIED. TENSION AND PRESSURE WERE APPLIED IN ATTEMPT TO CRUSH THE STONE, HOWEVER THE WIRE BROKE INSIDE THE RESCUE HANDLE. THE SHEATH SURROUNDING THE WIRE WAS THEN CUT TO MODIFY THE DEVICE AND GIVE MORE WIRE TO WRAP IN THE RESCUE HANDLE. THE EMERGENCY HANDLE WAS ABLE TO START TURNING THE WIRES AND THE STONE WAS THEN CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597384 ↗
• InjuryAug 22, 2023Break; Mechanical Problem; Break; Mechanical Problem

  WHEN THE ORIGINAL DEVICE WAS CONNECTED, NO PRESSURE WAS BEING APPLIED TO THE STONE AND THE HANDLE RETRACTED ALL THE WAY OUT AND THEN CONTINUED SPINNING. THE HANDLE WAS REATTACHED WITH THE SAME RESULT LEADING THE DEVICE TO FAIL, THEREFORE THE RESCUE DEVICE WAS APPLIED. TENSION AND PRESSURE WERE APPLIED IN ATTEMPT TO CRUSH THE STONE, HOWEVER THE WIRE BROKE INSIDE THE RESCUE HANDLE. THE SHEATH SURROUNDING THE WIRE WAS THEN CUT TO MODIFY THE DEVICE AND GIVE MORE WIRE TO WRAP IN THE RESCUE HANDLE. THE EMERGENCY HANDLE WAS ABLE TO START TURNING THE WIRES AND THE STONE WAS THEN CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597271 ↗
• MalfunctionMay 10, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH LITHOTRIPSY, THREE MECHANICAL LITHOTRIPTORS BROKE. THE TWO BULLET TIPS BROKE AND DID NOT CRUSH THE STONE. THE WIRE-GUIDED ONE ENDED UP BREAKING THE STONE FINALLY BUT IT ALSO BROKE IN THE PROCESS. THE PROCEDURE TOOK MUCH LONGER, AS REPORTED, BUT WAS COMPLETED. ADDITIONAL INFORMATION OBTAINED THAT EACH EXCHANGE WOULD TAKE ROUGHLY 2-5 MINUTES. THE DEVICES WERE INSPECTED BEFORE USE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: COMPLAINT (B)(6) - 1 OF 3 LITHOTRIPTORS. COMPLAINT (B)(6) - 2 OF 3 LITHOTRIPTORS. COMPLAINT (B)(6) - 3 OF 3 LITHOTRIPTORS. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907693 ↗
• MalfunctionMay 10, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH LITHOTRIPSY, THREE MECHANICAL LITHOTRIPTERS BROKE. THE TWO BULLET TIPS BROKE AND DID NOT CRUSH THE STONE. THE WIRE-GUIDED ONE ENDED UP BREAKING THE STONE FINALLY, BUT IT ALSO BROKE IN THE PROCESS. THE PROCEDURE TOOK MUCH LONGER, AS REPORTED, BUT WAS COMPLETED. ADDITIONAL INFORMATION OBTAINED THAT EACH EXCHANGE WOULD TAKE ROUGHLY 2-5 MINUTES. THE DEVICES WERE INSPECTED BEFORE USE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: COMPLAINT (B)(6) - 1 OF 3 LITHOTRIPTERS. COMPLAINT (B)(6) - 2 OF 3 LITHOTRIPTERS. COMPLAINT (B)(6) - 3 OF 3 LITHOTRIPTERS. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907535 ↗
• MalfunctionFeb 26, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE MECHANICAL LITHOTRIPTOR V JAMMED AFTER CAPTURING THE PATIENT¿S GALLSTONE. WHEN THE KNOB ON THE SLIDE WAS PUSHED FORWARD, THE SPIRAL TUBE JAMMED UP INSIDE. INITIALLY, THE BASKET COULD NOT BE RELEASED, AND THE BUTTON COULD NOT BE PUSHED BACK IN THE SLIDE. AFTER SEVERAL ATTEMPTS AND VARIOUS MOVEMENTS OF THE DUODENOVIDEOSCOPE, THE TENSION WAS RELEASED, AND THE STONE WAS REMOVED WITHOUT BEING CRUSHED. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE (STONE FRAGMENTATION ERCP), AND THE PROCEDURE WAS COMPLETED WITH THREE STONE RETRIEVAL BASKETS AND REPLACEMENT WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441173 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOME OF DIGITAL CHOLANGIOSCOPY AND LASER LITHOTRIPSY FOR IMPACTED BILIARY STONES." THE AIM OF THIS RETROSPECTIVE STUDY IS TO REPORT THE EFFICACY AND SAFETY OF INTRACORPOREAL LASER LITHOTRIPSY FOR IMPACTED STONES IN THE BILE DUCT IN THE 43 PATIENTS. THERE WERE 20 (46.51%) PATIENTS HAD SINGLE STONE, 35(81.39%) PATIENTS HAD ONLY BILE DUCT STONES, AND 8 (18.61%) PATIENTS HAD ADDITIONAL STONES IN CYSTIC DUCT OR INTRAHEPATIC BILIARY RADICAL. THIS STUDY CONCLUDED THAT INTRACORPOREAL LASER LITHOTRIPSY IS AN EFFECTIVE AND SAFE MODALITY FOR THE CLEARANCE OF IMPACTED BILE DUCT STONES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: CHOLANGITIS - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) (TJF-Q180V). (B)(6) (BML-V242QR-30). (B)(6) (FG-V425PR). THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 15925221 ↗
• InjurySep 29, 2022Break; Break

  THE CUSTOMER REPORTED THE FOLLOWING EVENT HAPPENED TWO (2) TIMES IN ONE MONTH INVOLVING THE SUBJECT DEVICE. THE FOLLOWING IS FOR PATIENT 1 OF 2 WHICH HAS BEEN REPORTED IN (B)(4). THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ERCP FOR A COMMON BILE DUCT (CBD) STONE RETRIEVAL, LAST THURSDAY, THE SUBJECT DEVICE WAS USED TO CRACK A LARGE STONE WHEN THE BASKET JAMMED WITHIN THE COMMON BILE DUCT. THE PIGMENT GALLSTONE WAS 12-15MM. THE SURGEON USED THE EMERGENCY MECHANICAL LITHOTRIPTOR BUT WAS UNABLE TO REMOVE THE BASKET. THE SURGEON FELT TENSION BETWEEN THE EMERGENCY MECHANICAL LITHOTRIPTOR AND THE CUT SUBJECT DEVICE. THE BREAKING POINT OF THE SUBJECT DEVICE WAS AT THE PROXIMAL END ONLY AND NOT THE DISTAL END WITH BASKET. SPYGLASS WAS USED TO COMPLETE THE PROCEDURE TO BREAK THE STONE AND REMOVE FROM CBD. IT IS UNCLEAR HOW THE BROKEN DEVICE WAS REMOVED FROM THE PATIENT. THE FOLLOWING IS FOR PATIENT 2 OF 2 AND IS BEING REPORTED IN (B)(4). THE CUSTOMER REPORTED THE EVENT FOR PATIENT 1 ALSO HAPPENED TO PATIENT 2. NO ADDITIONAL DETAILS PROVIDED. TWO EVENTS REPORTED: (B)(4): EVENT 1, (B)(4): EVENT 2. THIS REPORT IS 1 OF 2 FOR (B)(4): EVENT 1.

  Patient problems: Foreign Body In Patient

  MAUDE report 15501590 ↗
• InjurySep 29, 2022Break; Break

  THE CUSTOMER REPORTED THE FOLLOWING EVENT HAPPENED TWO (2) TIMES IN ONE MONTH INVOLVING THE SUBJECT DEVICE. THE FOLLOWING IS FOR PATIENT 1 OF 2 WHICH HAS BEEN REPORTED IN (B)(6). THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ERCP FOR A COMMON BILE DUCT (CBD) STONE RETRIEVAL, LAST THURSDAY, THE SUBJECT DEVICE WAS USED TO CRACK A LARGE STONE WHEN THE BASKET JAMMED WITHIN THE COMMON BILE DUCT. THE PIGMENT GALLSTONE WAS 12-15MM. THE SURGEON USED THE EMERGENCY MECHANICAL LITHOTRIPTOR BUT WAS UNABLE TO REMOVE THE BASKET. THE SURGEON FELT TENSION BETWEEN THE EMERGENCY MECHANICAL LITHOTRIPTOR AND THE CUT SUBJECT DEVICE. THE BREAKING POINT OF THE SUBJECT DEVICE WAS AT THE PROXIMAL END ONLY AND NOT THE DISTAL END WITH BASKET. SPYGLASS WAS USED TO COMPLETE THE PROCEDURE TO BREAK THE STONE AND REMOVE FROM CBD. IT IS UNCLEAR HOW THE BROKEN DEVICE WAS REMOVED FROM THE PATIENT. THE FOLLOWING IS FOR PATIENT 2 OF 2 AND IS BEING REPORTED IN (B)(6). THE CUSTOMER REPORTED THE EVENT FOR PATIENT 1 ALSO HAPPENED TO PATIENT 2. NO ADDITIONAL DETAILS PROVIDED. TWO EVENTS REPORTED: (B)(6): EVENT 1; (B)(6): EVENT 2. THIS REPORT IS 2 OF 2 FOR (B)(6): EVENT 2.

  Patient problems: Foreign Body In Patient

  MAUDE report 15501566 ↗
• InjuryJul 8, 2022Entrapment of Device; Entrapment of Device

  THE CUSTOMER REPORTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH COMMON BILE DUCT (CBD) STONE RETRIEVAL USING A SINGLE USE MECHANICAL LITHOTRIPTOR V, THE DEVICE WAS USED TO CRACK A LARGE STONE, BUT THE BASKET WAS ACCIDENTALLY JAMMED WITHIN THE COMMON BILE DUCT. EVEN THOUGH THE EMERGENCY MECHANICAL LITHOTRIPTOR WAS USED, THE BASKET STILL COULD NOT BE REMOVED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE A BOSTON SCIENTIFIC SPYGLASS WAS USED TO REMOVE THE INCARCERATED DEVICE. THE PATIENT WAS DISCHARGED. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED. THE SUBJECT DEVICE CANNOT BE RETURNED FOR EVALUATION, THE FACILITY WILL NOT ALLOW IT TO BE TAKEN OUT OF THE HOSPITAL BECAUSE IT WAS USED FOR A PATIENT WITH INFECTIOUS DISEASES. ADDITIONAL DETAILS REGARDING THE PATIENT/EVENT WERE REQUESTED. THIS INFORMATION COULD NOT BE PROVIDED DUE TO HONG KONG PRIVACY REGULATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 14956676 ↗
• MalfunctionNov 25, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE BASKET STEEL WIRE OF THE SUBJECT DEVICE WAS BROKEN TWICE DURING REMOVAL A LARGE AND HARD COMMON BILE DUCT (CBD) STONE PROCEDURE. THE STONE WAS SUCCESSFULLY CRUSHED AT THE THIRD ATTEMPT AND THE BASKET WAS REMOVED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12876370 ↗
• MalfunctionSep 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A STONE WAS STUCK IN THE SINGLE USE MECHANICAL LITHOTRIPTOR V AND INITIALLY COULD NOT BE REMOVED FROM THE PATIENT OR THROUGH THE ENDOSCOPE. THE FACILITY WAS PERFORMING THE PROCEDURE TO TRY TO CRUSH THE STONE AND THE STONE BECAME STUCK AND THE USER COULD NOT REMOVE THE DEVICE. THE STONES WERE CRUSHED WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) VIA THE SPYGLASS CATHETER PERCUTANEOUSLY VIA THE LIVER ACCESS. ONCE THE STONES WERE BROKEN UP ENOUGH THE MECHANICAL LITHOTRIPTOR WAS THEN REMOVED MANUALLY. IT WAS KNOWN FROM IMAGING THAT THE PATIENT HAD STONES, BUT THE AMOUNT OF MATERIAL AND THE SIZE OF THE STONES WERE UNKNOWN UNTIL ACCESS WAS OBTAINED. THIS WAS A CHALLENGING CASE AND WAS SCHEDULED WITH PERCUTANEOUS ACCESS ALSO. THERE WAS A TWO (2) HOUR DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE INTENDED PROCEDURE WAS COMPLETED BUT NOT WITH THE SAME DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED. IT WAS UNKNOWN IF THE DEVICE HAD EVER BEEN SERVICED BY A THIRD PARTY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525291 ↗
• MalfunctionOct 19, 2020Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE LITHOTRIPTER WIRE WAS CUT 20 CM FROM THE IMPACTED AND RETAINED GALL STONE. THE CUSTOMER REPORTED THAT MULTIPLE MANEUVERS WERE PERFORMED TO REMOVE THE BASKET, BUT WERE UNSUCCESSFUL. A NEW LITHOTRIPTER WAS USED TO REMOVE THE BASKET AND FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701495 ↗
• InjuryJul 27, 2020Difficult to Remove; Difficult to Remove

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE SUBJECT DEVICE WAS USED. THE NURSE FELT STRONG RESISTANCE WHEN THE USER TRIED TO CRUSH THE CALCULUS IN THE COMMON BILE DUCT. THE NURSE INFORMED THE DOCTOR THAT THERE WAS TOO MUCH RESISTANCE BUT THE DOCTOR ADVISED TO PROCEED. AFTER FEW TURNS OF THE HANDLE, THE OPERATING PIPE WAS BROKEN OFF. THE SUBJECT DEVICE COULD NOT BE REMOVED FROM THE PATIENT BODY. THE DOCTOR TRIED TO CRUSH THE CALCULUS WITH THE EMERGENCY LITHOTRIPTOR BUT THE MIDDLE OF THE OPERATING WIRE WAS BROKEN OFF. ONLY 6-8 INCHES OF THE WIRE WAS REMAINING FROM THE PATIENT'S MOUTH. THEY TRIED TO REMOVE THE SUBJECT DEVICE WITH THE GRASPING FORCEPS, BUT THE SUBJECT DEVICE COULD NOT BE REMOVED. THE USER PUSHED THE REMAINING WIRE INTO THE PATIENT'S STOMACH. THE DOCTOR DECIDED TO PUSH THE REMAINING WIRE INTO THE PATIENT'S STOMACH AND FIXED IT TO THE STOMACH WALL WITH CLIPS. IT WAS REPORTED THAT THE ADDITIONAL SURGERY WAS PLANNED TO REMOVE THE SUBJECT DEVICE AND THE CALCULUS FROM THE PATIENT BODY.

  Patient problems: No Code Available

  MAUDE report 10324722 ↗
• MalfunctionAug 9, 2018Break; Break

  DURING A CHOLELITHOTRIPSY, TWO OLYMPUS LITHOTRIPTORS WERE USED. THE WIRES OF THE TWO DEVICES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED. THIS IS A REPORT REGARDING THE BREAKAGE OF THE BASKET WIRE FOR THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766364 ↗
• MalfunctionAug 9, 2018Break; Break

  DURING A CHOLELITHOTRIPSY, TWO OLYMPUS LITHOTRIPTORS WERE USED. THE WIRES OF THE TWO DEVICES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED. THIS IS A REPORT REGARDING THE BREAKAGE OF THE BASKET WIRE FOR THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766361 ↗