Loop MAJ-340Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-340 20MM DETACHABLE NYLON LOOP 10/BX · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170045028), received between Feb 3, 2020 and Feb 3, 2020 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2020Difficult to Remove; Difficult to Remove
WE RECEIVED THE FOLLOWING REPORT. DURING A PROCEDURE, THE SUBJECT DEVICE WAS USED TO LIGATE POLYP. AFTER LIGATING THE POLYP, THE LOOP OF THE SUBJECT DEVICE COULD NOT BE RELEASED SINCE THE LOOP WAS PULLED INTO THE COIL SHEATH AND THE USER COULD NOT OPERATE THE HANDLE ANY MORE. THE USER USED LOOP CUTTER TO CUT THE LOOP. THE USER WITHDREW THE SUBJECT DEVICE FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE FAILURE OF RELEASING THE LOOP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9657876 ↗
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- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal1 recall239 reports
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- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal97 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135Olympus Medical Systems Corp. · Ligator, esophageal1 recall1 death10 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135LOlympus Medical Systems Corp. · Ligator, esophageal1 recall8 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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