COIL SHEATH MAJ-403Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-403 REPLACEMENT COIL SHEATH FOR EMER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170033025), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 COIL SHEATH USED. 2 OF 2 RELATED REPORTS, THE LITHOTRIPTOR DEVICE IS REFERENCED IN REPORTER FILE NO. (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10603035 ↗
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- 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 16, 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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