Snare Wire MAJ-11Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 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 04953170035999), received between Jun 16, 2022 and Jun 16, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE "UTILITY OF UNDERWATER EMR FOR NONPOLYPOID SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS =20 MM." LITERATURE SUMMARY. THIS RETROSPECTIVE STUDY ANALYZED THE UTILITY OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION FOR NONPOLYPOID SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS =20 MM. A TOTAL OF 132 PATIENTS (EMR 21 PATIENTS 23 SNADET, UEMR 60 PATIENTS 61 SNADET, EMRC 45 PATIENTS 48 SNADET) WERE INCLUDED. FOR ENDOSCOPIC RESECTION, UPPER ENDOSCOPE (GIF Q240Z, GIF Q260J, GIF H260Z, OR GIF-H290T; OLYMPUS ) WAS USED. FOR EMR AND EMRC, SALINE AND/OR 10% GLYCERIN SOLUTION (GLYCEOL; CHUGAI PHARMACEUTICAL ) WITH INDIGO CARMINE WAS ADMINISTERED FOR SUBMUCOSAL INJECTION. FOR SNARING OF EMR AND UEMR, A 10- TO 20-MM ELECTROCAUTERY SNARE (MAJ-11, MAJ-216, SNAREMASTER; OLYMPUS OR CAPTIVATOR; BOSTON SCIENTIFIC) WAS USED. IN EMRC, A TRANSPARENT CAP (MAJ-291 OR MAJ-296; OLYMPUS ) WITH AN OUTER DIAMETER OF 14.8 OR 16.1 MM WAS ATTACHED TO THE TIP OF THE ENDOSCOPE. A HALF MOON BRAIDED SNARE (SD-7P-1; OLYMPUS) WAS USED FOR SNARING. BOTH UEMR AND EMRC HAD A SIGNIFICANTLY HIGHER R0 RESECTION RATE THAN EMR. UEMR HAD SIGNIFICANTLY LOWER MULTIPLE RESECTION A
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation
MAUDE report 14717114 ↗
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- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
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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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