DISPOSABLE ELECTROSURGICAL SNARE SD-230U-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170328190), received between Oct 11, 2022 and Sep 20, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VALIDATION OF A NOVEL BCM MODEL FOR RECURRENCE RISK PREDICTION AFTER MUCOSECTOMY OF COLORECTAL LATERAL SPREADING TUMORS IN A EUROPEAN COHORT". LITERATURE SUMMARY: BACKGROUND AND AIM: PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION (PEMR) IS THE BEST APPROACH TO RESECT LARGE LATERAL SPREADING TUMORS (LST, > 20 MM WIDTH). HOWEVER, IT IS ASSOCIATED WITH EARLY RECURRENCE (ER) AND LATE RECURRENCE (LR). THIS STUDY AIMS TO ASSESS THE RISK FACTORS ASSOCIATED WITH ER AND LR AND TO VALIDATE DIFFERENT PREDICTIVE SCORES (SMSA, SERT, AND BCM) IN IDENTIFYING THE RISK OF ER AND LR AFTER LST RESECTED BY PEMR IN A EUROPEAN COHORT. METHODS: RETROSPECTIVE OBSERVATIONAL COHORT STUDY, BASED ON A PROSPECTIVELY COLLECTED DATABASE, OF LARGE LST SUBMITTED TO PEMR. RESULTS: A TOTAL OF 108 PATIENTS WERE INCLUDED IN THE STUDY AND THE INCIDENCE RATES OF ER AND LR WERE 22 % AND 8%, RESPECTIVELY. THE LESION¿S SIZE, SERT, AND BCM SCORES WERE INDEPENDENT PREDICTOR FACTORS OF ER (P-VALUE <0.05), WHILE THE LESION¿S SITE AND BCM SCORE WERE INDEPENDENT PREDICTOR FACTORS OF LR (P-VALUE < 0.05). FOR THE PREDICTION OF ER, THE SERT SCORE (CUT-OFF > 1) PRESENTED THE HIGHEST AUROC (0

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

  MAUDE report 20267993 ↗
• DeathApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AUTHOR THAT 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: Insufficient Information

  MAUDE report 19053615 ↗
• MalfunctionJan 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. THE INTENDED PROCEDURE WAS AN UNSPECIFIED THERAPEUTIC PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153612 ↗
• InjuryOct 26, 2022Loss of Power; Loss of Power

  THE CUSTOMER REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE CAUTERY FUNCTION FAILED ON THE SNARE WHEN ATTEMPTING TO REMOVE POLYP. THE SNARE HAD NO ELECTRICAL FUNCTION AND THE SURGEON WAS UNABLE TO REMOVE THE SNARE FROM THE POLYP AFTER MULTIPLE ATTEMPTS. THE SURGEON WAS UNABLE TO REMOVE THE SNARE AS IT WAS IMPACTED IN THE TISSUE. IT WAS MANUALLY REMOVED. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15677730 ↗
• MalfunctionOct 11, 2022Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTS DURING A POLYPECTOMY PROCEDURE USING A DISPOSABLE ELECTROSURGICAL SNARE, WHEN THE CAUTERY WAS ACTIVATED ON SPIRAL SNARE, THE CAUTERY DID NOT WORK. MAJ-860 CAUTERY CABLE WAS BEING USED WITH VIO300. SECOND VIO300 WAS BROUGHT INTO THE ROOM TO TROUBLE SHOOT. THE CAUTERY ON DISPOSABLE ELECTROSURGICAL SNARE STILL DID NOT ACTIVATE, SAME MAJ-860 CAUTERY CABLE WAS USED. THE SNARE COULD NOT BE REMOVED FROM LARGE POLYP, IT WAS IMPACTED. EVENTUALLY THE PHYSICIAN WAS ABLE TO PULL THE SNARE THROUGH THE POLYP WITHOUT CAUTERY, BUT WITH EXTREME DIFFICULTY AFTER 15+ MINUTES AND INCREASED PATIENT DISCOMFORT. THE SNARE WAS MANGLED, AT THE ATTACHMENT BETWEEN THE SHEATH AND HANDLE. A SECOND DISPOSABLE ELECTROSURGICAL SNARE WAS OPENED AND USED WITH THE SECOND VIO300 AND EXISTING MAJ-860 AND IT PERFORMED AS EXPECTED. THE REMAINING POLYP TISSUE WAS REMOVED WITHOUT FURTHER INCIDENT. THE NURSE AT THE BED SIDE DID MENTION THE SNARE DID NOT SEEM TO FUNCTION AS NORMAL AFTER REPEATED ATTEMPTS TO REMOVE THE SNARE. THE SNARE HAD BEEN OPENED AND CLOSED REPEATEDLY TO DETERMINE IF THE TISSUE HAD RELEASED AND IF THE MACHINERY WAS POTENTIALLY INVOLVED. AT THE FIRST ATTEMPT TO USE CAUTERY THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579292 ↗