DISPOSABLE ELECTROSURGICAL SNARE SD-210U-25 (REF 5686540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170037009), received between Sep 8, 2021 and Oct 15, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K902735); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿SUCCESSFUL ENDOSCOPIC RESECTION BY USING GEL IMMERSION AND THE TECHNIQUE OF ENDOSCOPIC PAPILLECTOMY FOR A TUMOR ADJACENT TO THE PAPILLA OF VATER¿. LITERATURE SUMMARY. INTRODUCTION. SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS ARE RARE, AND THE ESTABLISHMENT OF OPTIMIZED STRATEGIES FOR THEIR TREATMENT IS AN AREA OF ACTIVE INVESTIGATION. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS POSES THE RISK OF MAJOR ADVERSE EVENTS (AES), INCLUDING A HIGH RATE OF BLEEDING, INTRAOPERATIVE PERFORATION, AND DELAYED PERFORATION. LESIONS LOCATED IN THE DUODENAL FLEXURE ARE ASSOCIATED WITH POOR ENDOSCOPE MANEUVERABILITY. MOREOVER, ENDOSCOPIC RESECTION IS PARTICULARLY CHALLENGING FOR LESIONS ON THE DESCENDING DUODENUM¿S MEDIAL WALL, ESPECIALLY THOSE ADJACENT TO THE PAPILLA OF VATER (POV). IF ENDOSCOPIC RESECTION IS NOT POSSIBLE, A PANCREATICODUODENECTOMY, WHICH IS A HIGHLY INVASIVE SURGERY, CAN BE PERFORMED. GEL IMMERSION ENDOSCOPY IS USED TO CONTROL GASTROINTESTINAL BLEEDING BY FLUSHING OUT BLOOD AND CLOTS TO SECURE A GOOD VISUAL FIELD. SINCE THERE IS NO CARBON DIOXIDE (CO2) INSUFFLATION DURING D

  Patient problems: Perforation

  MAUDE report 23302590 ↗
• InjuryJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION INADVERTENTLY LEFT OUT: IT WAS REPORTED THAT THE NOOSE DID NOT REMAIN IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE GUIDEWIRE DETACHED INSIDE THE DUODENOSCOPE AND WAS FOUND TO BE OFF WHEN IT WAS PULLED OUT. ADDITIONALLY, THE FOREIGN OBJECT WAS A HYDRA JAGWIRE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808770 ↗
• InjuryJul 23, 2024Break; Break

  INFORMATION INADVERTENTLY LEFT OUT: IT WAS REPORTED THAT THE NOOSE DID NOT REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808539 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MIDDLE OF A THERAPEUTIC GASTROINTESTINAL ENDOSCOPIC MUCOSAL RESECTION (EMR) AND REMOVING THE POLYP (IN A MALE, JAPANESE PATIENT) A BURN WAS REPORTED WHICH WAS LARGER THAN USUAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND FEVER AFTER RETURNING HOME. UPON EXAMINATION, THE TISSUE WAS CAUTERIZED OVER A LARGER AREA THAN THE DOCTOR EXPECTED. THE BURN HAD SPREAD TO THE TISSUE. SO, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND REMAINED HOSPITALIZED. THE EXAMINATION REVEALED NO PERFORATION. THE BURN DID NOT EXTEND TO THE MUSCLE LAYER BUT FIVE CLIPS WERE USED TO STOP THE BLEEDING. FOLLOW UP INFORMATION REVEALED THAT THE PATIENT HAD A SECOND-DEGREE BURN AND ANTIBIOTICS WERE ADMINISTERED. A BLOOD TEST WAS PERFORMED AS A FOLLOW UP EXAMINATION AND INFLAMMATORY REACTION WAS NOTED.

  Patient problems: Abdominal Pain; Bowel Burn; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation

  MAUDE report 19515549 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS CORPORATION RECEIVED A LITERATURE TITLED "UNDERWATER VERSUS CONVENTIONAL EMR FOR NONPEDUNCULATED COLORECTAL LESIONS: A RANDOMIZED CLINICAL TRIAL". BACKGROUND AND AIMS: CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR) IS THE STANDARD MODALITY FOR REMOVING NONPEDUNCULATED COLORECTAL LESIONS. UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) HAS EMERGED AS AN ALTERNATIVE METHOD. THERE ARE FEW COMPARATIVE STUDIES BETWEEN THESE TECHNIQUES, ESPECIALLY EVALUATING RECURRENCE. THEREFORE, THE PURPOSE OF THIS TRIAL WAS TO COMPARE CEMR AND UEMR FOR THE RESECTION OF COLORECTAL LESIONS WITH RESPECT TO EFFICACY, SAFETY, AND RECURRENCE RATE. METHODS: THIS WAS A RANDOMIZED CONTROLLED TRIAL OF UEMR VERSUS CEMR FOR NAÏVE AND NONPEDUNCULATED LESIONS MEASURING BETWEEN 10 AND 40 MM. THE PRIMARY OUTCOME WAS ADENOMA RECURRENCE AT 6 MONTHS AFTER THE RESECTION. SECONDARY OUTCOMES WERE RATES OF TECHNICAL SUCCESS, EN BLOC RESECTION, AND ADVERSE EVENTS. BLOCK RANDOMIZATION WAS USED TO ASSIGN PATIENTS. TATTOOING WAS PERFORMED TO FACILITATE LOCALIZATION OF THE SCARS AND EVENTUAL RECURRENCES. ENDOSCOPIC FOLLOW-UP WAS SCHEDULED AT 6 MONTHS AFTER THE PROCEDURE. THE SITES OF RESECTIONS WERE EXAMINED WITH WHITE-

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18833744 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS CORPORATION RECEIVED A LITERATURE TITLED "UNDERWATER VERSUS CONVENTIONAL EMR FOR NONPEDUNCULATED COLORECTAL LESIONS: A RANDOMIZED CLINICAL TRIAL". BACKGROUND AND AIMS: CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR) IS THE STANDARD MODALITY FOR REMOVING NONPEDUNCULATED COLORECTAL LESIONS. UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) HAS EMERGED AS AN ALTERNATIVE METHOD. THERE ARE FEW COMPARATIVE STUDIES BETWEEN THESE TECHNIQUES, ESPECIALLY EVALUATING RECURRENCE. THEREFORE, THE PURPOSE OF THIS TRIAL WAS TO COMPARE CEMR AND UEMR FOR THE RESECTION OF COLORECTAL LESIONS WITH RESPECT TO EFFICACY, SAFETY, AND RECURRENCE RATE. METHODS: THIS WAS A RANDOMIZED CONTROLLED TRIAL OF UEMR VERSUS CEMR FOR NAÏVE AND NONPEDUNCULATED LESIONS MEASURING BETWEEN 10 AND 40 MM. THE PRIMARY OUTCOME WAS ADENOMA RECURRENCE AT 6 MONTHS AFTER THE RESECTION. SECONDARY OUTCOMES WERE RATES OF TECHNICAL SUCCESS, EN BLOC RESECTION, AND ADVERSE EVENTS. BLOCK RANDOMIZATION WAS USED TO ASSIGN PATIENTS. TATTOOING WAS PERFORMED TO FACILITATE LOCALIZATION OF THE SCARS AND EVENTUAL RECURRENCES. ENDOSCOPIC FOLLOW-UP WAS SCHEDULED AT 6 MONTHS AFTER THE PROCEDURE. THE SITES OF RESECTIONS WERE EXAMINED WITH WHITE-

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18833706 ↗
• MalfunctionDec 1, 2023Off-Label Use; Off-Label Use

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISPOSABLE ELECTROSURGICAL SNARE COLD SNARE OPTION DOES NOT WORK AND THEY HAD TO CHANGE TO HOT SNARE DURING PROCEDURE AND THEY NOTICED THE PACKAGE DOES NOT MENTION COLD SNARE AT ALL. THE PROCEDURE WAS FINISHED WITH THE HOT OPTION. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246462 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE PHYSICIAN THAT THE SHEATH OF THE SUBJECT DEVICE COULD NOT BE RETRACTED AND THE SUBJECT DEVICE COULD NOT BE PUT OFF A POLYP AFTER THE SURGEON LIGATED THE POLYP DURING A POLYPECTOMY ON SIGMOID COLON. THE SURGEON DETACHED THE HANDLE OF THE SUBJECT DEVICE AND REMOVED THE ENDOSCOPE. THE SURGEON RE-INSERTED THE ENDOSCOPE AND TRIED TO RETRACT THE SHEATH OF SUBJECT DEVICE USING A FORCEPS BUT COULD NOT DO IT. THE SURGEON USED A SURGICAL ELECTRONIC SNARE (SD-210U-25) AND COULD CUT THE POLYP AT TWO POINTS (AT THE UPPER OF AND THE BOTTOM OF SNARE), BECAUSE THE POLYP WAS LARGE. HOWEVER, DURING CUTTING THE POLYP AT THE UPPER OF SNARE, THE MUCOUS MEMBRANE IN THE VICINITY WAS ELECTRICALLY DAMAGED, AND FEVER WAS OBSERVED THE NEXT DAY. THE PATIENT WAS HOSPITALIZED FOUR DAYS LONGER THAN PLANNED. THE SURGEON DID NOT USE A LOOP CUTTER TO RETRACT THE SHEATH DURING THE PROCEDURE. OMSC WILL SUBMIT A REPORT OF HX-400U-30, AND ANOTHER OF SD-210U-25. THIS IS THE REPORT FOR SD-210U-25.

  Patient problems: Fever

  MAUDE report 12444141 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K902735. One submission often covers many models, so check the product and lot details in each record.

• Z-1070-2021 · Jan 4, 2021 · Terminated
  CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-0986-2021 · Jan 4, 2021 · Terminated
  SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-0984-2021 · Jan 4, 2021 · Terminated
  SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-0985-2021 · Jan 4, 2021 · Terminated
  SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
• Z-1071-2021 · Jan 4, 2021 · Terminated
  CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.