DISPOSABLE ELECTROSURGICAL SNARE SD-240U-25 (REF N1083430)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of DISPOSABLE ELECTROSURGICAL SNARE (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170165986), received between Apr 17, 2019 and Sep 8, 2023 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 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 18, 2026.
Most reported problems
Device problems
- Difficult to Remove2
- Failure to Cut2
- Adverse Event Without Identified Device or Use Problem1
- Therapeutic or Diagnostic Output Failure1
- Use of Device Problem1
Patient problems
- Bowel Perforation3
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Perforation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2023Difficult to Remove; Failure to Cut; Difficult to Remove; Failure to Cut
AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING AN UNSPECIFIED PROCEDURE, THE DISPOSABLE ELECTROSURGICAL SNARE COULD NOT CUT THROUGH A LARGE POLYP (25 MILLIMETER). ALSO, THE SNARE LOOP COULD NOT BE REMOVED FROM THE TARGET TISSUE. THE HANDLE WAS CUT OFF SNARE AND THE DOCTOR WAS ABLE TO PUSH THE SCOPE FORWARD TO RELEASE SNARE AND REMOVE SCOPE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17712703 ↗InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE USER FACILITY THAT DURING A POLYP REMOVAL PROCEDURE USING A SD-240U-25 DISPOSABLE ELECTROSURGICAL SNARE, THE POLYP COULD NOT BE REMOVED. THE CAUTERY UNIT AND THE SNARE WERE CHANGED TWICE, WITHOUT SUCCESS. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND UNDERWENT A COLON RESECTION WITH A ILEOSTOMY SURGERY TO REPAIR THE PERFORATION. THE PATIENT DISCHARGED TWO WEEKS LATER. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.
Patient problems: Bowel Perforation
MAUDE report 8917762 ↗InjuryAug 19, 2019Use of Device Problem; Use of Device Problem
IT WAS REPORTED BY THE USER FACILITY THAT DURING A POLYP REMOVAL PROCEDURE USING A SD-240U-25 DISPOSABLE ELECTROSURGICAL SNARE, THE POLYP COULD NOT BE REMOVED. THE CAUTERY UNIT AND THE SNARE WERE CHANGED TWICE, WITHOUT SUCCESS. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND UNDERWENT A COLON RESECTION WITH A ILEOSTOMY SURGERY TO REPAIR THE PERFORATION. THE PATIENT DISCHARGED TWO WEEKS LATER. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.
Patient problems: Perforation
MAUDE report 8906772 ↗InjuryAug 19, 2019Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT DURING A POLYP REMOVAL USING A SD-240U-25, THE POLYP COULD NOT BE REMOVED. THE PHYSICIAN CHANGED THE CAUTERY UNIT AND SNARE DEVICE TWICE WITHOUT SUCCESS. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR ADDITIONAL MEDICAL INTERVENTION DUE TO BOWEL PERFORATION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Bowel Perforation
MAUDE report 8906308 ↗InjuryAug 19, 2019Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS USING A SD-240U-25 FOR A POLYPECTOMY, BUT THE POLYP COULD NOT BE REMOVED. THE SNARE AND THE CAUTERY UNIT WERE CHANGED TWICE WITHOUT SUCCESS. THE PATIENT HAD TO BE TRANSFERRED TO THE HOSPITAL DUE TO A BOWEL PERFORATION, AND REMAINED IN THE HOSPITAL 2 WEEKS FOR RECOVERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO HOME.
Patient problems: Bowel Perforation
MAUDE report 8906277 ↗MalfunctionApr 17, 2019Difficult to Remove; Difficult to Remove
OLYMPUS WAS INFORMED THAT DURING A POLYPECTOMY PROCEDURE, THE SNARE BECAME STUCK THE PATIENT¿S POLYP. THE POLYP WAS CONSIDERED TO BE MODERATE IN SIZE AND FIRM. THERE WAS NO BLEEDING OBSERVED. THE PHYSICIAN USED PLIERS AND APPLIED FORCE TO REMOVE THE SNARE LOOP. THE POLYP WAS CLOSE TO THE PATIENT¿S RECTUM, SO THE PHYSICIAN WAS ABLE TO REMOVE IT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PATIENT'S CURRENT CONDITION IS STABLE. ADDITIONALLY, THE SNARE WAS TESTED WITH CURRENT PRIOR TO THE PROCEDURE WITH NO ANOMALIES NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8525484 ↗
Other SNARE, FLEXIBLE devices
- CAPTIFLEX M00562400Boston Scientific Corporation · SNARE, FLEXIBLE3 recalls85 reports
- SENSATION Short Throw M00562670Boston Scientific Corporation · SNARE, FLEXIBLE1 recall178 reports
- SENSATION Short Throw M00562650Boston Scientific Corporation · SNARE, FLEXIBLE1 recall173 reports
- Ultratome XL M00535900Boston Scientific Corporation · SNARE, FLEXIBLE205 reports
- CAPTIVATOR M00562340Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls71 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls32 reports
- CAPTIVATOR M00562300Boston Scientific Corporation · SNARE, FLEXIBLE1 recall78 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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