MECHANICAL LITHOTRIPTOR BML-110A-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170033001), received between Nov 11, 2019 and Jan 11, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2023Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION FROM THE USER FACILITY VIA A COMPANY REPRESENTATIVE INDICATED THAT THE PATIENT HAD NO SIGNIFICANT HEALTH PROBLEMS DUE TO THE SURGERY AND WAS DISCHARGED WITH THE SAME MEASURES AS USUAL. THE HOSPITAL STAY WAS NOT PROLONGED. IT WAS STATED THAT THE PATIENT WAS YOUNG AND STILL HAD A SMALL AMOUNT OF SMALL COMMON BILE DUCT STONES, WHICH WILL BE REMOVED AGAIN THE FOLLOWING MONTH. IT WAS ADDITIONALLY STATED THAT THE STAFF DID NOT UNDERSTAND HOW TO USE THE BML-110A WELL. WHEN IT WAS USED TO TRY AND CRUSH THE STONE MECHANICALLY, THE PATIENT COMPLAINED OF PAIN. THE PATIENT WAS "IN TROUBLE", WHICH IS WHEN THE SURGEON ATTEMPTED TO DILATE. IT WAS CLARIFIED THAT THERE WAS NO PARTICULAR PROBLEM WITH THE BML-110A IN TERMS OF USABILITY.

  Patient problems: Intraoperative Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142271 ↗
• MalfunctionJan 6, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED A CASE OF A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WAS INCARCERATED WHILE USING THE SINGLE USE RETRIEVAL BASKET V. TO RELEASE THE INCARCERATION, A MECHANICAL LITHOTRIPTER WAS USED. WHEN THE CUSTOMER CUT THE SHEATH ON THE PROXIMAL SIDE OF THE RETRIEVAL BASKET, IT WAS CUT SHORT AND IT DID NOT COME OUT. BY CUTTING AND SHORTENING THE COIL SHEATH SIDE OF THE LITHOTRIPTER, THE HANDLE COULD BE CONNECTED AND RELEASED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE EQUIPMENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111152 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE ENDOSCOPIC SCOPE AND JAG WIRE INSERTED FOR THE INTENDED PROCEDURE. THE JAG WIRE FED THROUGH OLYMPUS SHEATH AND INTO THE HANDLE. THE SHEATH CONNECTED TO HANDLE AND SCREWED INTO PLACE. THE WIRE TIGHTENED IN ORDER TO ADVANCE TO UPPER GI (GASTROINTESTINAL). DURING THE RETRIEVAL OF THE WIRE AND SCOPE FROM THE STOMACH, THE STAFF NOTICED THE PATIENT "HEMORRHAGING" FROM THE MOUTH. THIS REPORT IS IN REFERENCE TO THE LITHOTRIPTOR USED. 1 OF 2 RELATED REPORTS, THE COIL SHEATH DEVICE IS REFERENCED IN REPORTER FILE NO. (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10603055 ↗
• MalfunctionNov 11, 2019Difficult to Remove; Difficult to Remove

  THE MANUFACTURER WAS INFORMED THAT DURING A PROCEDURE THE DEVICE BECAME STUCK IN THE PATIENT'S BILE DUCT AREA. THE DOCTOR REPORTED THAT THE ATTACHED HANDLE WAS CUT OFF FROM THE BASKET WIRE AND ATTACHED THE EMERGENCY HANDLE. INSTEAD, SINCE THE DOCTOR IS ON A FLUOROSCOPY WITH THE PATIENT SO THE DOCTOR COULD VIEW IN REAL TIME ON WHAT IS GOING ON AT THE TROUBLE AREA. THE DOCTOR WAS ABLE TO CRUSH THE STUCK STONE FROM THE AREA AND WITHDRAW THE WHOLE WIRE BASKET FROM THE PATIENT. THERE WAS NO ADDITIONAL SURGERY REQUIRED. THERE WAS NO SERIOUS INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304492 ↗