DISPOSABLE ELECTROSURGICAL SNARE SD-210U-10 (REF 5686340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170036941), received between Mar 15, 2022 and Mar 30, 2022 — classified as 6 injuries.

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.

• InjuryMar 30, 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 POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10) HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) - REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953609 ↗
• InjuryMar 30, 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 POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10). HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953590 ↗
• InjuryMar 30, 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 POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10) HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953542 ↗
• InjuryMar 30, 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 POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10) HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953538 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE TITLED ¿RISK FACTORS OF DELAYED BLEEDING AFTER COLD SNARE POLYPECTOMY FOR COLORECTAL POLYPS: A MULTICENTER STUDY,¿ PATIENTS EXPERIENCED DELAYED BLEEDING (DB) AFTER COLD SNARE POLYPECTOMY (CSP) PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AZI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290I. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290ZI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-HQ290I. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SD-210L-10. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SD-400U-10. STUDY BACKGROUND/AIM: DELAYED BLEEDING (DB) RARELY OCCURS AFTER COLD SNARE POLYPECTOMY (CSP) FOR COLORECTAL POLYPS, BUT NO LARGE-SCALE STUDIES HAVE INVESTIGATED THIS. THE STUDY EVALUATED THE RATE, CHARACTERISTICS, AND RISK FACTORS OF DB OF CSP. METHODS: A MULTICENTER RETROSPECTIVE STUDY AT 10 (B)(6) INSTITUTIONS. A TOTAL OF 18,007 PATIENTS UNDERWENT CSP FOR COLORECTAL POLYPS = 10 MM IN SIZE FROM MARCH 2015 TO SEPTEMBER 2019, AND CASES OF DB (DB GROUP) WERE ANALYZED FOR THE RATE, ANTITHROMBOTIC DRUGS, POLYP SIZE, MORPHOLOGY, LOCATION, AND RISK FACTORS. AS A C

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13949589 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS, THREE DAYS AFTER A COLONOSCOPY PROCEDURE USING A DISPOSABLE ELECTROSURGICAL SNARE (WITH AN ESG-100 GENERATOR, NM-400U-0423, AND SERIES 260 SCOPE) , THE PATIENT PRESENTED AT ANOTHER HOSPITAL FOR A BOWEL PERFORATION. IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT OF THE PERFORATION. THE PATIENT'S CURRENT CONDITION COULD NOT BE PROVIDED. THERE IS NO REPORT OF ANY DEVICE MALFUNCTION DURING THE PROCEDURE. WHEN THE EVENT WAS WAS REPORTED, THE CUSTOMER WAS UNSURE IF THERE HAVE BEEN AN ELECTRICAL SURGE THAT HAD AFFECTED THE EQUIPMENT AND WANTED IT EVALUATED. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) EVALUATED THE ESG-100 GENERATOR ON SITE AND FOUND NO ISSUE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DISPOSABLE SNARE USED IN THE PROCEDURE (THIS REPORT). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE GENERATOR USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE INJECTOR USED IN THE PROCEDURE.

  Patient problems: Bowel Perforation

  MAUDE report 13770634 ↗

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.