DISPOSABLE ELECTROSURGICAL SNARE SD-210U-10 (REF N3642440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170298417), received between Apr 19, 2022 and Dec 2, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K902735); they may or may not involve this specific model.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THE ELECTROSURGICAL SNARE WAS NOT ABLE TO REMOVE THE POLYP DUE TO A WIRE FAILURE. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE (COLON SCREENING), WHICH WAS COMPLETED WITH A SIMILAR (NON-OLYMPUS) DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694343 ↗
• MalfunctionMay 7, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THE SUBJECT DEVICE SNARE WAS NOT COMPLETELY OPENED DURING SNARE CAUTERIZATION. THE SNARE TIP WAS REPORTED AS SLIGHTLY SLANTED AND DID NOT WORK AS INTENDED. THIS ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC MUCOSAL RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979720 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.

  Patient problems: Perforation

  MAUDE report 18986045 ↗
• InjuryJan 13, 2023Failure to Cut; Failure to Cut

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING THE DISPOSABLE ELECTROSURGICAL SNARE, AFTER SNARING A LARGE POLYP, THE PHYSICIAN COULD NOT CUT OR RETRACT THE SNARE. THE SNARE AND POLYP BOTH HAD TO BE SURGICALLY REMOVED FROM THE PATIENT; THE PATIENT WAS TAKEN TO SURGERY IMMEDIATELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; DESPITE MULTIPLE ATTEMPTS, NONE HAS BEEN RECEIVED. IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158857 ↗
• InjuryJan 13, 2023Difficult to Remove; Retraction Problem; Failure to Cut

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING THE DISPOSABLE ELECTROSURGICAL SNARE, AFTER SNARING A LARGE POLYP, THE PHYSICIAN COULD NOT CUT OR RETRACT THE SNARE. THE SNARE AND POLYP BOTH HAD TO BE SURGICALLY REMOVED FROM THE PATIENT; THE PATIENT WAS TAKEN TO SURGERY IMMEDIATELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; DESPITE MULTIPLE ATTEMPTS, NONE HAS BEEN RECEIVED. IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

  Patient problems: Laceration(s)

  MAUDE report 16158107 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: ¿COMPARISON OF COLD SNARE POLYPECTOMY AND ENDOSCOPIC MUCOSAL RESECTION FOR 3¿10-MM COLORECTAL POLYPS IN END-STAGE RENAL DISEASE PATIENTS,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER COLD SNARE POLYPECTOMY PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SD-210U-10 USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE CH-Q260AI USED IN THE PROCEDURES. STUDY AIM: COMPARE THE EFFICACY AND SAFETY OF CSP AND ENDOSCOPIC MUCOSAL RESECTION (EMR) IN ESRD PATIENTS. METHOD: THIS STUDY WAS A RETROSPECTIVE STUDY. WE PERFORMED PROPENSITY SCORE-MATCHED ANALYSIS IN PATIENTS WITH ESRD WHO UNDERWENT ENDOSCOPIC RESECTION FOR 3¿10-MM-SIZED COLORECTAL POLYPS AT SEOUL ST. MARY¿S HOSPITAL, FROM JANUARY 2014 TO DECEMBER 2019. RESULTS: AFTER 1:1 RATIO MATCHING, 406 POLYPS WERE INCLUDED: 203 POLYPS WERE RESECTED WITH CSP AND 203 POLYPS WITH EMR. THERE WAS NO DIFFERENCE BETWEEN THE CSP GROUP AND EMR GROUP IN INCOMPLETE RESECTION RATE (4.43% VS. 1.97%, P = 0.16). THERE WERE NO DIFFERENCES BETWEEN THE CSP AND EMR GROUP FOR IMMEDIATE BLEEDING (5.42% VS. 7.88%, P = 0.32) AND DELAYED BLEEDING (0% VS. 0.49%, P = 1.00). NO PE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ulcer; Unspecified Gastrointestinal Problem

  MAUDE report 14141550 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K902735. One submission often covers many models, so check the product and lot details in each record.

• Z-1070-2021 · Jan 4, 2021 · Terminated
  CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-1071-2021 · Jan 4, 2021 · Terminated
  CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-0985-2021 · Jan 4, 2021 · Terminated
  SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-0986-2021 · Jan 4, 2021 · Terminated
  SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-0984-2021 · Jan 4, 2021 · Terminated
  SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.