DISPOSABLE ELECTROSURGICAL SNARE SD-210U-15 (REF 5686440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170036972), received between Sep 7, 2023 and Feb 25, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Heating” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOSCOPIC MUCOSAL RESECTION OF GASTROINTESTINAL POLYPS WITH A NOVEL LOW-TEMPERATURE PLASMA RADIO FREQUENCY GENERATOR: A NON-INFERIORITY MULTI-CENTER RANDOMIZED CONTROL STUDY."     ¿LITERATURE SUMMARY¿ ABSTRACT BACKGROUND TO EVALUATE THE EFFICACY AND SAFETY OF NOVEL PLASMA RADIO FREQUENCY GENERATOR AND ITS SINGLE-USE POLYPECTOMY SNARES FOR ENDOSCOPIC MUCOSAL RESECTION (EMR) OF GASTROINTESTINAL (GI) POLYPS. METHODS A TOTAL OF 217 PATIENTS WITH 413 GI POLYPS WERE RECRUITED FROM FOUR CENTERS IN CHINA. PATIENTS WERE ASSIGNED TO EXPERIMENTAL OR CONTROL GROUPS USING A CENTRAL RANDOMIZATION METHOD. THE EXPERIMENTAL GROUP USED THE NOVEL PLASMA RADIO FREQUENCY GENERATOR AND ITS MATCHED SINGLE-USE POLYPECTOMY SNARES (NEOWING, SHANGHAI), WHILE THE CONTROL GROUP USED THE HIGH-FREQUENCY ELECTROSURGICAL UNIT (ERBE, GERMANY) AND DISPOSABLE ELECTROSURGICAL SNARES (OLYMPUS, JAPAN). THE PRIMARY ENDPOINT WAS THE EN BLOC RESECTION RATE, AND THE NON-INFERIORITY MARGIN WAS SET AT 10%. SECONDARY ENDPOINT INCLUDED OPERATION TIME, COAGULATION SUCCESS RATE, INTRAOPERATIVE AND POSTOPERATIVE BLEEDING RATE, AND PERFORATION RATE. RESULTS THE EN

  Patient problems: Abdominal Pain; Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18774977 ↗
• MalfunctionSep 7, 2023Insufficient Heating; Insufficient Heating

  A BIOMEDICAL ENGINEERING REPORTED TO OLYMPUS, THE DISPOSABLE ELECTROSURGICAL SNARE WOULD NOT CAUTERIZE ON INSIDE OF SNARE. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17704147 ↗

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-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-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-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.