ELECTROSURGICAL SNARE SD-9U-1Recalls & 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 04953170036200), received between Oct 4, 2020 and Oct 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
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.
InjuryOct 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOSCOPIC TREATMENT OF INTRADUCTAL PANCREATIC STENT FRAGMENTATION". THE LITERATURE REPORTED THE RESULT OF 33 PATIENTS WITH ENDOSCOPIC TREATMENT OF INTRADUCTAL PANCREATIC STENT FRAGMENTATION USING UNSPECIFIED ENDOSCOPE AND OLYMPUS ROTATABLE GRASPING FORCEPS (FG-44NR-1 OR FG-V422PR) OR ELECTROSURGICAL SNARE (SD-9U-1) FROM 2001 TO 2015. IN THE SUBJECT CASES, PERIAMPULLARY DUODENAL BLEEDING OCCURRED IN 2 PATIENTS. THEREFORE, OMSC WILL SUBMIT 2 MEDICAL DEVICE REPORTS (MDR) DEPENDING ON THE DEVICE AND EVENT TYPE. THIS REPORT IS 2 OF 2 REPORTS OF ELECTROSURGICAL SNARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10624707 ↗
Other ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL devices
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- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 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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