Single Use BML Handle V MAJ-2502Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170433658), received between Apr 30, 2024 and Jul 17, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED THE FOLLOWING ISSUE: AFTER THE GALL STONE WAS CRUSHED, THE HANDLE COULD NOT BE RELEASED FROM POSITION ¿2¿ AND WAS JAMMED IN THE RATCHET POSITION. HANDLE BROKE WHILST TRYING TO DISENGAGE RATCHET WHILST INSIDE PATIENT. THE ISSUE OCCURRED DURING A THERAPEUTIC ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22535511 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECPW) PROCEDURE, THE STONE HAD ALREADY BEEN CAUGHT AND WAS ABOUT TO BE CRUSHED, THE KNOB FOR CRUSHING/CLOSING THE BASKET BROKE OFF WITH THE SUBJECT DEVICE STUCK. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322844 ↗InjuryApr 30, 2024Break; Break
IT WAS REPORTED THAT DURING LITHOTRIPSY, THE ANCHORING OF THE LITHOTRIPTER BASKET WAS TORN OUT AND THE HANDLE WAS BROKEN. EMERGENCY LITHOTRIPSY HAD TO PERFORMED USING A METAL COIL, DURING WHICH NOT ONLY WAS THE STONE NOT FRAGMENTED, BUT INSTEAD OF A FRACTURE ON THE CUP ITSELF, ONLY ONE OF THE WIRES AT THE TOP WAS TORN. FURTHER BASKETS THEN GOT CAUGHT IN THE OLYMPUS BASKET, AND A CHOLANGIOSCOPY WITH LASER LITHOTRIPSY COULD ONLY PARTIALLY FRAGMENT THE STONE. THE PATIENT HAD TO UNDERGO EMERGENCY SURGERY AFTER A 3.5-HOUR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BASKETS THAT COULD NOT BE REMOVED. THE BASKET WAS REMOVED DURING THE EMERGENCY OPERATION. REPORTEDLY, APART FROM THE STONE ITSELF AND FAILURE OF THE PRIMARY LITHOTRIPSY, THE MAIN PROBLEM WAS THAT THE BASKET WAS NOT SUITABLE FOR EMERGENCY LITHOTRIPSY VIA SPIRAL. IT WAS FURTHER ELABORATED, THERE WAS A SMOOTH PASSAGE TO THE PARS DESCENDENS DUODENI, WHERE A PLASTIC STENT IN-SITU WAS REMOVED. THE PARS DESCENDENS DUODENI WAS RE-ACCESSED AND IT WAS NOTED THAT THE OSTIUM OF THE BILE DUCT WAS LYING DEEP IN A DIVERTICULUM. CANNULATION USING AN ERCP CATHETER AND WIRE WAS DONE WITH WIRE ADVANCEMENT TO THE INTRAHEPATIC. CON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19216055 ↗
Other Lithotriptor, Biliary Mechanical devices
- Trapezoid RX M00510890Boston Scientific Corporation · Lithotriptor, biliary mechanical482 reports
- Single Use Mechanical Lithotriptor V BML-V442QR-30Olympus Medical Systems Corp. · Lithotriptor, biliary mechanical1 recall1 death269 reports
- Trapezoid RX M00510880Boston Scientific Corporation · Lithotriptor, biliary mechanical1 death287 reports
- Trapezoid RX M00510870Boston Scientific Corporation · Lithotriptor, biliary mechanical149 reports
- Trapezoid RX M00510860Boston Scientific Corporation · Lithotriptor, biliary mechanical1 death53 reports
- Single Use Mechanical Lithotriptor V BML-V437QR-30Olympus Medical Systems Corp. · Lithotriptor, biliary mechanical33 reports
- Single Use Mechanical Lithotriptor V BML-V437QR-30Olympus Medical Systems Corp. · Lithotriptor, Biliary Mechanical21 reports
- Single Use Mechanical Lithotriptor V BML-V242QR-30Olympus Medical Systems Corp. · Lithotriptor, biliary mechanical21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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