DISPOSABLE ELECTROSURGICAL SNARE SD-221U-25 (UDI 04953170037047)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170037047), received between Oct 9, 2020 and May 12, 2023 — 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.

• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION OF GASTRIC NEOPLASIA: A RANDOMIZED CONTROLLED TRIAL". THIS MULTICENTER, RANDOMIZED CONTROLLED TRIAL AIMED TO ASSESS THE EFFICACY OF CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE (CSM-PLT) IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 378 PATIENTS WERE FINALLY INCLUDED IN THE PER-PROTOCOL ANALYSIS. THE MEAN PROCEDURE TIMES WERE 69.7 AND 58.0 MIN FOR THE CONVENTIONAL ESD AND CSM-PLT GROUPS, INDICATING THAT THE PROCEDURE WAS SIGNIFICANTLY SHORTER IN THE CSM-PLT GROUP (P=0.009). THE R0 RESECTION RATE TENDED TO BE HIGHER IN THE CSM PLT GROUP THAN IN THE CONVENTIONAL ESD GROUP (P=0.09). THE MEAN PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE NOVICE (P=0.04), TUMOR SIZE =20 MM (P=0.02), AND IT KNIFE (P=0.045) GROUPS. THE MEAN PREPARATION TIME FOR CSM-PLT WAS 2.3 MIN. CSM-PLT METHOD SHORTENED THE ESD PROCEDURE TIME. MOREOVER, CSM-PLT IS SAFE, DOES NOT INCREASE COMPLICATION RATES, AND IS ASSOCIATED WITH BETTER R0 RESECTION RATES THAN CONVENTIONAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION - 5

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16918098 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 14, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "IMPACT OF THE CLIP AND SNARE METHOD USING THE PRELOOPING TECHNIQUE FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION". THIS STUDY WAS CONDUCTED THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR COLORECTAL TUMORS ON 140 PATIENTS BETWEEN JANUARY 2010, AND MAY 2014. THE SUBJECT DEVICE AND THE CLIPS WERE USED DURING THE ESD. IN THE LITERATURE, IT WAS REPORTED THAT COMPLICATIONS OF 4 CASES OF PERFORATION AND 7 CASES OF POSTOPERATIVE BLEEDING WERE OCCURRED DURING THE COLORECTAL ESD USING THE SUBJECT DEVICE. THERE ARE NO DESCRIPTIONS OF DEVICE RELEVANCE FOR THE POSTOPERATIVE BLEEDING AND THE PERFORATION IN THE LITERATURE. 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 ENDOSCOPIC RESECTION OF THE SUBMUCOSAL LAYER. THEREFORE, OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) AS THE EVENT TYPE FOR THE 4 CASES OF THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 10655445 ↗