DISPOSABLE ELECTROSURGICAL SNARE SD-221L-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170326356), received between Nov 2, 2020 and Feb 9, 2022 — classified as 2 injuries.

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 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "STUDY OF 109 CASES BY ENDOSCOPIC TREATMENT (ANTI-REFLUX MUCOSECTOMY: ARMS) FOR ACID SECRETION INHIBITOR (PPI) RESISTANT REFRACTORY GASTROESOPHAGEAL REFLUX DISEASE (GERD) (WITH VIDEO) ", THREE PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER AN ENDO-REFLUX MUCOSECTOMY (ARMS) USING A DISPOSABLE ELECTROSURGICAL SNARE. STUDY AIM: INVESTIGATE THE EFFICACY OF ARMS IN PATIENTS WITH PPI REFRACTORY GERD. METHOD: RETROSPECTIVE REVIEW OF 109 PATIENTS WITH PPI REFRACTORY GERD WHO UNDERWENT ARMS AND COMPARED THE QUESTIONNAIRE SCORES, ACID-EXPOSURE TIMES, NUMBER OF DEMEESTER SCORE, PROXIMAL REFLUX, AND PPI DISCONTINUATION RATES BEFORE AND AFTER ARMS. RESULTS: SUBJECTIVE SYMPTOMS WERE SIGNIFICANTLY IMPROVED (P<0.01) AND PPI COULD BE DISCONTINUED IN 40-50% OF THE PATIENTS AFTER ARMS. IN ADDITION, IMPROVEMENT IN SUBJECTIVE SYMPTOMS WAS MAINTAINED IN THE 3-YEAR FOLLOW-UP PATIENTS. ACID-EXPOSURE TIME OR DEMEESTER SCORE IMPROVED AFTER ARMS (P<0.01), BUT PROXIMAL REFLUX DID NOT IMPROVE SIGNIFICANTLY (P=0.0846). CONCLUSION: ARMS IS A VALUABLE MINIMALLY INVASIVE TREATMENT FOR PEOPLE WITH PPI REFRACTORY GERD. THE EFFECTIVENESS OF TREATMENT IS DUE TO INHIBITION

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13498125 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 7, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "HOW TO MANAGE PERFORATION RELATED TO ENDOSCOPIC RESECTION OF SUPERFICIAL CANCER". THIS STUDY WAS REPORTED ENDOSCOPIC MUCOSAL RESECTION (EMR) OF A 5MM LARGE LESION OF THE ESOPHAGUS USED THE SUBJECT DEVICE. IN THE LITERATURE, IT WAS REPORTED THAT INTEROPERATIVE PERFORATION HAS OCCURRED. THE MUCOSAL RESECTION WAS IMPLEMENTED WITH THE SUBJECT DEVICE, AND THE DEFECT OF THE MUSCULAR SECTION WAS CONFIRMED. THE PERFORATION WAS MANAGED BY APPLYING ENDOSCOPIC CLIPPING. AFTER SURGERY, FASTING AND ANTIBACTERIAL TREATMENT WERE PERFORMED, AND THE PATIENT WAS DISCHARGED ON THE 8TH DAY. THERE ARE NO DESCRIPTIONS OF DEVICE RELEVANCE FOR ALL ADVERSE EVENTS IN THE LITERATURE. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, DETAILED INFORMATION OF THE SUBJECT DEVICE WAS NOT PROVIDED. WHEREAS, OMSC ASSUMES THAT THE PERFORATION WAS RELATED TO THE SUBJECT DEVICE DUE TO OCCURRED DURING THE PROCEDURE. THEREFORE, OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) FOR THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 10769893 ↗