ELECTROSURGICAL SNARE SD-12U-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170036460), received between Dec 13, 2021 and Dec 14, 2021 — 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.

• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "EVALUATION OF FACTORS ASSOCIATED WITH EN BLOC COLONIC UNDERWATER ENDOSCOPIC MUCOSAL RESECTION". THE PURPOSE OF THIS LITERATURE WAS TO EVALUATE THE FACTORS ASSOCIATED WITH A SUCCESSFUL EN BLOC RESECTION USING UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) TO PROVIDE INFORMATION FOR THE CLINICIANS TO SELECT WHICH PATIENTS ARE ELIGIBLE FOR UEMR. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; THE STUDY COMPRISED 160 PATIENTS WHO WERE 173 COLORECTAL POLYPS WERE REMOVED WITH UEMR. OF ALL 160 PATIENTS, 101 (63.1%) PATIENTS WERE MALE, AND THE MEAN AGE WAS 65.17 ± 11.73 YEARS OLD (RANGE: 30-91 YEARS OLD). THIRTEEN (7.5%) OF THE PATIENTS HAD MORE THAN ONE POLYP DURING THE PROCEDURE AND RECEIVED MORE THAN ONE UEMRS. COLONOSCOPIES WERE PERFORMED WITH A CONVENTIONAL COLONOSCOPE (CF-Q260AL, CF-H290L) OR A MAGNIFYING PEDIATRIC COLONOSCOPE (PCF-Q260AZI). A TRANSPARENT HOOD (D-201-13 404) WAS APPLIED FOR EVERY COLONOSCOPY. AN OVAL STANDARD POLYPECTOMY SNARE (SD-12U-1, SD-210U-25, OR SD-230U-20) WAS USED DEPENDING ON THE LESION SIZE. AFTER THE POLYP WAS FIRMLY SNARED, THE SURGEON RESECTED IT WITH AN INTERRUPTED CUT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12998247 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 29, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "EVALUATION OF FACTORS ASSOCIATED WITH EN BLOC COLONIC UNDERWATER ENDOSCOPIC MUCOSAL RESECTION".THE PURPOSE OF THIS LITERATURE WAS TO EVALUATE THE FACTORS ASSOCIATED WITH A SUCCESSFUL EN BLOC RESECTION USING UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) TO PROVIDE INFORMATION FOR THE CLINICIANS TO SELECT WHICH PATIENTS ARE ELIGIBLE FOR UEMR.IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS;THE STUDY COMPRISED 160 PATIENTS WHO WERE 173 COLORECTAL POLYPS WERE REMOVED WITH UEMR. OF ALL 160 PATIENTS, 101 (63.1%) PATIENTS WERE MALE, AND THE MEAN AGE WAS 65.17 ± 11.73 YEARS OLD (RANGE: 30-91 YEARS OLD). THIRTEEN (7.5%) OF THE PATIENTS HAD MORE THAN ONE POLYP DURING THE PROCEDURE AND RECEIVED MORE THAN ONE UEMRS.COLONOSCOPIES WERE PERFORMED WITH A CONVENTIONAL COLONOSCOPE (CF-Q260AL, CF-H290L) OR A MAGNIFYING PEDIATRIC COLONOSCOPE (PCF-Q260AZI). A TRANSPARENT HOOD (D-201-13 404) WAS APPLIED FOR EVERY COLONOSCOPY.AN OVAL STANDARD POLYPECTOMY SNARE (SD-12U-1, SD-210U-25, OR SD-230U-20) WAS USED DEPENDING ON THE LESION SIZE. AFTER THE POLYP WAS FIRMLY SNARED, THE SURGEON RESECTED IT WITH AN INTERRUPTED CU

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12982242 ↗