BML Handle V MAJ-441Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170218446), received between Apr 5, 2023 and Dec 26, 2024 — classified as 1 death, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A THERAPEUTIC ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) UNDER SEDATION, AN ATTEMPT WAS MADE TO RELEASE IMPACTION USING THE HANDLE, BUT IT COULD NOT BE RELEASED. THE GUIDEWIRE OF THE SINGLE USE MECHANICAL LITHOTRIPTER WAS TANGLED IN THE BASKED. AFTER THE BASKET WAS REMOVED, THE ENBD WAS PLACED IN THE BILE DUCT AND THE PROCEDURE WAS COMPLETED. DUE TO THE DEVICE MALFUNCTIONS, THE PROCEDURE WAS PROLONGED BY 45 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21022209 ↗
• DeathApr 29, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED, THE PATIENT UNDERWENT A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR GALLSTONE REMOVAL, AND A SIGNIFICANT STONE 13X20 WAS DETECTED IN THE COMMON BILE DUCT. THE STONE WAS CAPTURED IN A MECHANICAL LITHOTRIPTER BASKET INSERTED INTO AN OLYMPUS V SYTEM STONE CRUSHER. WHEN BREAKING THE STONE, THE WIRE BROKE AT THE HANDLE, NOT AT THE PREFORMED PART OF THE BASKET. THUS, THE WIRE AND STONE WERE STUCK AT THE EXIT OF THE BILE DUCT. THE WIRE WAS THEN CLAMPED INTO THE EMERGENCY LITHOTRIPTER, BUT IT WAS STILL NOT POSSIBLE TO BREAK THE STONE AND THE WIRE BROKE AGAIN AT THE HANDLE, NOT THE BASKET. THE DEVICE WAS REMOVED AND THE PATIENT WAS TAKEN TO URGENT SURGERY DUE TO THE DEVICE MALFUNCTION. THE OPERATION WAS PERFORMED THAT AFTERNOON, BUT THE PATIENT DIED AT DAWN THE NEXT DAY. THE PHYSICIAN DID NOT SEE A CONNECTION BETWEEN THE DEATH AND THE DEVICE FAILURE, BUT THE FAILURE IS WHAT STARTED THE CHAIN OF EVENTS.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 19208197 ↗
• MalfunctionMar 8, 2024Break; Device Reprocessing Problem; Break; Device Reprocessing Problem

  IT WAS REPORTED, THE BML HANDLE GRIP ON THE OPERATING PIPE WAS WEAK AND CAME LOOSE. THE ISSUE OCCURRED DURING PREPERATION FOR A THERAPEUTIC LITHOTRIPSY PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866029 ↗
• InjuryDec 13, 2023Break; Break

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT AT THE END OF THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY ERCP PROCEDURE IN A 80 YEAR OLD, CAUCASIAN, FEMALE PATIENT, THE MAJ-441, 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, PATIENT FULLY RECOVERED AND WAS DISCHARGED. NO PRE-EXISTING PATIENT CONDITIONS WERE REPORTED.NO DELAY AND NO USER ERROR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317506 ↗
• InjuryDec 13, 2023Break; Break

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT AT THE END OF THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY ERCP PROCEDURE IN A 80 YEAR OLD, CAUCASIAN, FEMALE PATIENT, THE MAJ-441, 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, PATIENT FULLY RECOVERED AND WAS DISCHARGED. NO PRE-EXISTING PATIENT CONDITIONS WERE REPORTED. NO DELAY AND NO USER ERROR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317502 ↗
• InjuryDec 1, 2023Difficult to Remove; Difficult to Remove

  OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT THE PATIENT DID NOT HAVE ANY COMPLICATIONS FROM THE INCARCERATION. THE PATIENT WAS HOSPITALIZED IN THE FACILITY WHERE THE BASKET WAS REMOVED BUT WAS NOT ADMITTED TO THE ICU. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247601 ↗
• MalfunctionOct 25, 2023Problem with Sterilization; Mechanical Jam; Problem with Sterilization; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION FOR USE, THE LOCK ON THE FRONT OF THE BML HANDLE V DID NOT ENGAGE. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER ALSO REPORTED THAT DURING REPROCESSING, ULTRASONIC CLEANING WAS USED AND DID NOT USE AUTOCLAVE STERILIZATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000912 ↗
• MalfunctionOct 25, 2023Problem with Sterilization; Mechanical Jam; Problem with Sterilization; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION FOR USE, THE LOCK ON THE FRONT OF THE BML HANDLE V DID NOT ENGAGE. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER ALSO REPORTED THAT DURING REPROCESSING, ULTRASONIC CLEANING WAS USED AND DID NOT USE AUTOCLAVE STERILIZATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000563 ↗
• MalfunctionOct 24, 2023Device Reprocessing Problem; Device Reprocessing Problem

  A CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION FOR USE, THE LOCK (STICKING STOPPER AND STICKING WIRE CONTACT RELEASE BUTTON) ON FRONT OF THE BML HANDLE V DID NOT ENGAGE. THE THERAPEUTIC LITHOTRIPSY WAS COMPLETED USING A SIMILAR REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE¿S CLEANING STERILIZATION AND DISINFECTION IS ULTRASONIC CLEANING AND NOT AUTOCLAVE IS USED. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996635 ↗
• MalfunctionJun 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE USER ATTEMPTED TO CRUSH THE BILE DUCT STONE WITH THE BML-V437QR-30 (SINGLE USE MECHANICAL LITHOTRIPTOR V), HOWEVER, IT WAS DIFFICULT BECAUSE THE STONE WAS HARD. IT WAS NOTED, WHEN THE KNOB OF THE BML HANDLE V WAS TURNED FORCEFULLY, THE CONNECTING PART BETWEEN THE BML SHEATH AND THE HANDLE BROKE. SUBSEQUENTLY, THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, WITH NO DELAY AND NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES THE RELATED EVENT ON THE SINGLE USE MECHANICAL LITHOTRIPTOR V.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215827 ↗
• MalfunctionApr 5, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BASKET COULD NOT BE REMOVED WHILE USING BML HANDLE V DURING A THERAPEUTIC PROCEDURE LITHOTRIPSY ELECTROMAGNETIC EML. THE SINGLE USE MECHANICAL LITHOTRIPTOR V BML WAS REMOVED TOGETHER WITH THE SCOPE, AND ANOTHER JF-260V AND BML WERE USED TO COMPLETE THE PROCEDURE. AFTER CONFIRMING THE MALFUNCTIONING SCOPE AND INSTRUMENT, IT WAS CONFIRMED THAT THE BML SHEATH WAS CAUGHT IN THE FORCEPS ELEVATOR. IT WAS ALSO CONFIRMED THAT THE BML SHEATH COULD NOT BE REMOVED FROM THE BML HANDLE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS FOR THE BML HANDLE V (MODEL NUMBER: MAJ-441, SERIAL NUMBER: (B)(4). PATIENT IDENTIFIER (B)(4) CAPTURES THE COMPLAINT ON THE EVIS LUCERA DUODENOVIDEOSCOPE (MODEL UMBER: JF-260V, SERIAL NUMBER: (B)(4). PATIENT IDENTIFIER (B)(6) CAPTURES THE COMPLAINT ON THE SINGLE USE MECHANICAL LITHOTRIPTOR V (MODEL NUMBER BML-V437QR-30, SERIAL NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681642 ↗