DISPOSABLE ELECTROSURGICAL SNARE SD-240U-25 (REF N3642930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170298462), received between Oct 23, 2018 and Apr 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Disconnect” (1 report).

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.

• InjuryApr 22, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE SNARE WAS STUCK AND TWISTED ON A POLYP, WHILE USING THE ENDOTHERAPY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155944 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNDERWATER ENDOSCOPIC SUBMUCOSAL DISSECTION AND HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION AS RESCUE THERAPY IN DIFFICULT COLORECTAL CASES". THIS RETROSPECTIVE ANALYSIS DEMONSTRATES THAT UNDERWATER ESD (U-ESD) AND HYBRID ESD (H-ESD) ARE BOTH EFFECTIVE AND SAFE AS RESCUE THERAPY IN DIFFICULT COLORECTAL ESD. THERE WERE FIFTY-NINE COLORECTAL NEOPLASMS WERE CONSIDERED, 22 OF WHICH WERE REMOVED BY U-ESD AND 37 BY H-ESD. THE EN BLOC RESECTION RATE IN THE U-ESD GROUP WAS 100%, WHILE IT WAS 59.5% IN THE H-ESD GROUP. DISSECTION SPEED WAS 17.7MM2/MIN IN THE U-ESD GROUP AND 8.3MM2/MIN IN THE H-ESD GROUP. THIS STUDY CONCLUDES THAT THE U-ESD AND H-ESD ARE BOTH EFFECTIVE AND SAFE TECHNIQUES IN DIFFICULT COLORECTAL SITUATIONS. U-ESD IS PARTICULARLY EFFECTIVE AND FAST FOR LARGE LESIONS WHEN IT IS NOT POSSIBLE TO OBTAIN COMFORTABLE KNIFE POSITION, WHILE H-ESD IS MORE SUITABLE FOR VERY FIBROTIC LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS [UNDERWATER ESD], BACTEREMIA - 1 PATIENT [HYBRID ESD], PERFORATION - 4 PATIENTS, BLEEDING - 4 PATIENTS, BACTEREMIA - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS F

  Patient problems: Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16090129 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING THE MIDDLE OF A COLONOSCOPY PROCEDURE, THE DEVICE TORE A PATIENT¿S MUCOSA WHILE THE DOCTOR WAS WITHDRAWING THE SNARE OUT OF THE PATIENT¿S COLON. THE USER FACILITY REPORTED THERE WAS NO ISSUE WITHDRAWING THE SNARE FROM THE SCOPE AS THERE WERE NO RESTRICTIONS NOTED DURING INSERTION OR WITHDRAWAL OF THE SNARE. THE USER FACILITY ALSO REPORTED THERE WAS NO TREATMENT, INTERVENTION OR ADDITIONAL PROCEDURE REQUIRED TO THE PATIENT AS THE USER FACILITY REPORTED THERE WAS SLIGHT TISSUE TEAR AND MINOR BLEEDING WHICH SUBSIDED ON IT'S OWN. THE PATIENT DID NOT REQUIRE A LONGER STAY AS THE PATIENT WAS DISCHARGED ON THE SAME DAY. THE USER FACILITY PERFORMED A FOLLOW UP WITH THE REPORTED PATIENT AND THE PATIENT IS DOING FINE. NO OTHER INSTRUMENTS WERE USED DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH SAME EQUIPMENT. THE USER FACILITY REPORTED THE SCOPE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT AS THERE WAS NO ISSUE NOTED WITH THE SCOPE WHEN THE REPORTED EVENT OCCURRED. THERE WAS NO IMAGE, PARTIAL OR COMPLETE, LOST DURING THE PROCEDURE. ALTHOUGH THEY DID NOT NOTICE ANY ISSUES DURING THE PROCEDURE, THEY DO NOT KNOW THE CAUSE, BUT BELIEVE THE

  Patient problems: Tissue Damage

  MAUDE report 7997121 ↗