DISPOSABLE ELECTROSURGICAL SNARE SD-210U-25 (REF N3642640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170298431), received between Apr 29, 2022 and Feb 6, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE LITERATURE TITLED "EFFICACY AND SAFETY OF NOVEL HEMOSTATIC GEL IN ENDOSCOPIC SPHINCTEROTOMY OR ENDOSCOPIC PAPILLECTOMY: A MULTICENTER, RANDOMIZED CONTROLLED CLINICAL TRIAL." BACKGROUND: ENDOSCOPISTS OFTEN EXPERIENCE OBSTACLES WITH TRADITIONAL HEMOSTASIS USING THE SIDE-VIEWING DUODENOSCOPE FOR BLEEDING AFTER ENDOSCOPIC SPHINCTEROTOMY (EST) OR ENDOSCOPIC PAPILLECTOMY (EP). AIMS: IN THIS RANDOMIZED CONTROLLED TRIAL, WE EVALUATED THE EFFICACY AND SAFETY OF A NOVEL HEMOSTATIC GEL FOR POST-EST OR POST-EP BLEEDING. METHODS: A RANDOMIZED TRIAL WAS CONDUCTED FROM NOVEMBER 2020 TO DECEMBER 2021 AT TWO TERTIARY CENTERS IN SOUTH KOREA. PATIENTS WHO EXPERIENCED BLEEDING IMMEDIATELY AFTER EST OR EP WERE ENROLLED IN THE STUDY, AND PRIMARY HEMOSTASIS WAS ACHIEVED WITH EITHER THE NOVEL HEMOSTATIC GEL OR EPINEPHRINE SPRAY. RESULTS: A TOTAL OF 84 PATIENTS WERE ENROLLED IN THIS STUDY, AND 41 PATIENTS WERE FINALLY ANALYZED IN EACH GROUP. HEMOSTATIC GEL WAS SIGNIFICANTLY SUPERIOR TO EPINEPHRINE SPRAY FOR SUCCESSFUL PRIMARY HEMOSTASIS (100% VS. 85.4%; P = 0.026). ). IN TERMS OF DELAYED BLEEDING, NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN THE HEMOSTATIC GEL AND EPINEPHRINE SPRAY (

  Patient problems: Abdominal Pain; Fever; Pancreatitis

  MAUDE report 18650580 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "ENDOSCOPIC MUCOSAL RESECTION OF GASTROINTESTINAL POLYPS WITH A NOVEL PLASMA RADIOFREQUENCY GENERATOR--A NON-INFERIORITY MULTICENTER RANDOMIZED CONTROL STUDY'" PATIENT'S EXPERIENCED ADVERSE EFFECTS DURING/AFTER PROCEDURES. AIM: TO EVALUATE THE EFFICACY AND SAFETY OF NOVEL PLASMA RADIOFREQUENCY GENERATOR FOR ENDOSCOPIC MUCOSAL RESECTION (EMR) OF GASTROINTESTINAL POLYPS. METHODS: FROM OCTOBER 2019 TO MAY 2021, 217 CASES OF GASTROINTESTINAL POLYPS WERE INCLUDED FROM 4 CENTERS IN CHINA. AMONG THEM, 206 CASES WERE COLORECTAL POLYPS AND 12 CASES WERE GASTRIC POLYPS (1 CASE HAD BOTH). ALL THE CASES WERE RANDOMLY ASSIGNED TO EITHER THE EXPERIMENTAL GROUP (107 CASES) OR THE CONTROL GROUP (110 CASES). THE EXPERIMENTAL GROUP USED THE NOVEL PLASMA RADIOFREQUENCY GENERATOR AND ITS MATCHED DISPOSABLE ELECTRIC SNARES, WHILE THE CONTROL GROUP USED THE HIGH-FREQUENCY ELECTROSURGICAL SYSTEM (ERBE, GERMANY) AND DISPOSABLE ELECTRIC SNARES (OLYMPUS, JAPAN). THE PRIMARY OUTCOME WAS THE EN BLOC RESECTION RATE. SECONDARY OUTCOMES INCLUDED OPERATIVE TIME, COAGULATION SUCCESS RATE, INTRAOPERATIVE AND POSTOPERATIVE BLEEDING RATE, AND PERFORATION RATE. RESULTS: THE EN B

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15312810 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "EFFICACY AND SAFETY OF COLD VERSUS HOT SNARE POLYPECTOMY FOR SMALL (5-9 MM) COLORECTAL POLYPS: A MULTICENTER RANDOMIZED CONTROLLED TRIAL."     LITERATURE SUMMARY: THIS STUDY COMPARED COLD SNARE POLYPECTOMY (CSP) AND HOT SNARE POLYPECTOMY (HSP) IN 5¿9MM POLYPS IN TERMS OF COMPLETE RESECTION AND ADVERSE EVENTS. 496 PATIENTS WERE RANDOMIZED: 237 (394 POLYPS) TO CSP AND 259 (397 POLYPS) TO HSP. COMPLETE POLYPECTOMY RATES WERE 92.5% WITH CSP AND 94.0% WITH HSP (DIFFERENCE 1.5%, 95% CONFIDENCE INTERVAL ¿1.9% TO 4.9%). INTRAPROCEDURAL BLEEDING OCCURRED DURING THREE CSPS (0.8 %) AND SEVEN HSPS (1.8%) (P = 0.34). ONE LESION PER GROUP (0.4 %) PRESENTED DELAYED HEMORRHAGE. POST COLONOSCOPY ABDOMINAL PAIN PRESENTED SIMILARLY IN BOTH GROUPS 1 HOUR AFTER THE PROCEDURE (CSP 18.8% VS. HSP 18.4%) BUT WAS HIGHER IN THE HSP GROUP AFTER 5 HOURS (5.9% VS. 16.5%; P = 0.02). A HIGHER PROPORTION OF PATIENTS WERE ASYMPTOMATIC 24 HOURS AFTER CSP THAN AFTER HSP (97% VS. 86.4%; P=0.01). THIS SHOWED NO DIFFERENCES IN COMPLETE RESECTION AND BLEEDING RATES BETWEEN CSP AND HSP. CSP REDUCED THE INTENSITY AND DURATION OF POST-COLONOSCOPY ABDOMINAL PAIN.     TYPE O

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14251347 ↗

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-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-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-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-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-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.