DISPOSABLE ELECTROSURGICAL SNARE SD-210U-15 (REF N3642540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170298424), received between Jul 27, 2021 and Sep 20, 2024 — classified as 9 injuries.

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 9 most recent of 9 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 20268014 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN A CLINICAL STUDY PATIENT, COLONOSCOPY WAS PERFORMED AT AN OUTPATIENT CLINIC, AND POLYPS WERE REMOVED FROM 20 LESIONS FROM THE CECUM TO THE RECTUM. ONE LESION IN THE ASCENDING COLON AND ONE LESION IN THE TRANSVERSE COLON WERE DEEMED ELIGIBLE FOR THIS STUDY, AND THE PATIENT WAS ENROLLED IN THE STUDY AND UNDERWENT PROTOCOL TREATMENT. THERE WERE NO ADVERSE EVENTS DURING SURGERY, AND THE PATIENT WAS DISCHARGED THE SAME DAY. LATER, ON THE NIGHT AFTER THE SURGICAL PROCEDURE, THE PATIENT VISITED THE EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. AFTER DETAILED EXAMINATION, THE PATIENT WAS DIAGNOSED WITH DELAYED PERFORATION AFTER POLYPECTOMY. EMERGENCY SURGERY WAS PERFORMED ON THE SAME DAY, AND A PERFORATION WAS FOUND IN THE CECUM CONTRALATERAL TO THE ILEOCECAL REGION, AND A PARTIAL APPENDECTOMY AND LAVAGE DRAINAGE WERE PERFORMED. THE SITE OF THE PERFORATION WAS THE SITE WHERE APPENDICEAL ADENOMA HAD BEEN REMOVED WITH HOT SNARE POLYPECTOMY AND TREATED ACCORDING TO THE PROTOCOL, AND IT HAS BEEN DETERMINED THAT THERE IS NO PROBLEM WITH CONTINUING THE CLINICAL STUDY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO REPORTS OF FURTHER PATIENT HARM/INJURY.

  Patient problems: Abdominal Pain; Bowel Perforation

  MAUDE report 20242169 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "COLORECTAL POST-POLYPECTOMY BLEEDING IN OUTPATIENT VERSUS INPATIENT TREATMENT: PROPENSITY SCORE MATCHING ANALYSIS". LITERATURE SUMMARY OBJECTIVES: DELAYED BLEEDING IS THE MOST FREQUENT ADVERSE EVENT ASSOCIATED WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) AND HOT SNARE POLYPECTOMY (HSP) OF COLORECTAL POLYPS. HOWEVER, WHETHER THE INCIDENCE OF DELAYED BLEEDING DIFFERS BETWEEN OUTPATIENT AND INPATIENT TREATMENT IS UNKNOWN. THEREFORE, IN THIS STUDY, WE AIMED TO EVALUATE DELAYED BLEEDING RATES BETWEEN OUTPATIENT AND INPATIENT ENDOSCOPIC TREATMENTS AND CLARIFY THE SAFETY OF OUTPATIENT TREATMENT. METHODS: WE ENROLLED 469 PATIENTS (1077 POLYPS) AND 420 PATIENTS (1080 POLYPS) IN THE OUTPATIENT AND INPATIENT GROUPS, RESPECTIVELY, WHO UNDERWENT EMR OR HSP FOR COLORECTAL POLYPS AT OUR INSTITUTION BETWEEN (B)(6) 2023. USING PROPENSITY SCORE MATCHING, WE EVALUATED THE DELAYED BLEEDING RATES BETWEEN THE TWO GROUPS. DELAYED BLEEDING WAS DEFINED AS A HEMORRHAGE REQUIRING ENDOSCOPIC HEMOSTASIS OCCURRING WITHIN 14 DAYS OF THE PROCEDURE. RESULTS: PROPENSITY SCORE MATCHING CREATED 376 (954 POLYPS) MATCHED PATIENT PAIRS. THE MEDIAN MAXIMUM DIA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20145753 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VWS02-3 TREATMENT OUTCOMES OF ENDOSCOPIC PAPILLECTOMY FOR DUODENAL PAPILLA CANCER". LITERATURE SUMMARY [BACKGROUND] THERE IS NO CONSENSUS ON THE INDICATIONS FOR ENDOSCOPIC PAPILLECTOMY (EP) FOR DUODENAL PAPILLA CANCER. [OBJECTIVE] TO INVESTIGATE THE SAFETY AND PROGNOSIS OF EP FOR DUODENAL PAPILLA CANCER. [METHOD] AMONG 77 CASES OF PAPILLA TUMORS WHO UNDERWENT EP BETWEEN MAY 2002 AND OCTOBER 2023, 33 CASES (4 TIS, 25 T1A (M), 2 T1A (OD), AND 2 T1B (DU)) WITH A FINAL PATHOLOGICAL DIAGNOSIS OF ADENOCARCINOMA WERE INCLUDED. WE COMPARED THE EN BLOC RESECTION RATE, PATHOLOGICAL COMPLETE RESECTION RATE, ADVERSE EVENTS, RECURRENCE RATE, AND RECURRENCE PATTERN WITH 44 ADENOMA CASES FROM THE SAME PERIOD AS CONTROLS. [RESULTS] THE EN BLOC RESECTION RATE AND PATHOLOGICAL COMPLETE RESECTION RATE WERE 94% (31/33) AND 42% (14/33) FOR ADENOCARCINOMA AND 89% (39/44) AND 52% (23/44) FOR ADENOMA (P=0.69, 0.49, RESPECTIVELY). EARLY ADVERSE EVENTS WERE OBSERVED IN 30% (10/33) OF ADENOCARCINOMA PATIENTS (7 CASES OF BLEEDING, 4 CASES OF PANCREATITIS, 4 CASES OF PERFORATION, 1 CASE OF CHOLANGITIS) AND 36% (16/44) OF ADENOMA PATIENTS (10 CASES OF BLEEDING,

  Patient problems: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Stenosis; Unspecified Hepatic or Biliary Problem

  MAUDE report 19619967 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT THE AUTHOR HAS CONFIRMED THAT THE ADVERSE EVENTS DESCRIBED IN THE LITERATURE WERE NOT FROM THE OLYMPUS DEVICES AND THAT THERE WAS NO MALFUNCTION OF ANY KIND WITH THE OLYMPUS DEVICES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17807707 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "A CASE OF LUMP-SUM RESECTION OF A DUODENAL PAPILLARY TUMOR WITH LATERAL EXTENSION BY EP WITH HYBRID ESD" A PATIENT EXPERIENCED A POSTERIOR HEMORRHAGE REQUIRING ENDOSCOPIC HEMOSTASIS. PATIENT/BACKGROUND/PROCEDURE: A MALE IN HIS 60S UNDERWENT A TOTAL COLORECTAL RESECTION AT THE AGE OF 42 BY HIS PREVIOUS PHYSICIAN DUE TO A HISTORY OF FAMILIAL ADENOMATOUS POLYPOSIS (FAP) AND HAD BEEN FOLLOWED UP REGULARLY SINCE THEN. HE WAS REFERRED TO OUR DEPARTMENT FOR CLOSE EXAMINATION AND TREATMENT AFTER MULTIPLE DUODENAL TUMORS WERE DETECTED DURING EGD AT HIS PREVIOUS DOCTOR. EGD SHOWED A DUODENAL PAPILLARY TUMOR OF LESS THAN 30 MM IN DIAMETER WITH WHITE OPAQUE SUBSTANCE (WOS). AFTER CLOSE EXAMINATION BY ENDOSCOPIC ULTRASOUND (EUS) AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A DIAGNOSIS OF DUODENAL PAPILLARY ADENOMA WITHOUT EXTENSION INTO THE PANCREATICOBILIARY DUCT WAS MADE. SINCE THE PAPILLARY TUMOR HAD LATERAL EXTENSION TO THE ANORECTAL SIDE, IT WAS CONSIDERED DIFFICULT TO SECURE NEGATIVE MARGINS BY CONVENTIONAL ENDOSCOPIC PAPILLARY RESECTION (EP). WE PLANNED TO PERFORM AN EN BLOC RESECTION BY EP WITH HYBRID ESD, IN WHICH THE TUMOR IS RESE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15844346 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿REAL-WORLD LOCAL RECURRENCE RATE AFTER COLD POLYPECTOMY IN COLORECTAL POLYPS LESS THAN 10 MM USING PROPENSITY SCORE MATCHING,¿ PATIENTS EXPERIENCED ACUTE BLEEDING EVENTS DURING PROCEDURES USING AN OLYMPUS COLONOSCOPE AND USING SNAREMASTER. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-H260AZI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-HQ290I. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SD-210U-15. BACKGROUND AND AIMS: COLD POLYPECTOMY (CP) IS A SIMPLE AND SAFE PROCEDURE FOR POLYPS LESS THAN 10 MM IN SIZE; HOWEVER, THERE IS CONCERN ABOUT LOCAL RECURRENCE FOLLOWING CP BECAUSE OF UNIDENTIFIED MARGINS OF EXCISED SPECIMENS AND THE LACK OF TUMOR SUPPRESSION EFFECT BY COAGULATION. SOME CLINICAL TRIALS HAVE EVALUATED LOCAL PERSISTENT RECURRENCE; THEIR RESULTS SUGGEST THAT A HIGHER RATE OF LOCAL RECURRENCE HAS NOT BEEN DOCUMENTED SO FAR. THERE WERE FEW REPORTS THAT OBSERVED THE COURSE OVER LONG PERIODS OF TIME AFTER CP IN CLINICAL PRACTICE. THIS STUDY¿S AIM WAS TO EVALUATE THE PRESENCE OF LOCAL RECURRENCE FOLLOWING CP AND HOT POLYPECTOMY (HP) USING PROPENSITY SCORE MATCHING. METHOD: THIS STUDY ANALYZED 275 PATIENTS WHO UNDERWENT POLYPECTOMY FOR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13969992 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿SINGLE-DUCT STENTING AND EST-ADDITIONAL PROCEDURES AFTER ENDOSCOPIC PAPILLECTOMY: BILE DUCT STENTING AND/OR ENDOSCOPIC SPHINCTEROTOMY,¿ A PATIENT EXPERIENCED CHOLANGITIS AFTER A PROCEDURE USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE TJF-260V USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE SD-210U-15 USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE OLYMPUS ESG-100 USED IN THE PROCEDURES. INTRODUCTION/ STUDY AIM: ENDOSCOPIC PAPILLECTOMY (ENDOSCOPIC PAPILLECTOMY: EP) IS BECOMING A WIDESPREAD RESECTION TECHNIQUE FOR DUODENAL PAPILLOMA. ONE OF THE MOST MINIMALLY INVASIVE BUT RISKY ENDOSCOPIC PROCEDURES COMPARED TO SURGICAL TREATMENT, AND PREVENTION OF ACCIDENTAL DISEASE IS IMPORTANT. SINCE EP WAS FIRST REPORTED IN JAPAN, IT WILL BE ABOUT 40 YEARS, BUT THE PROCEDURE HAS NOT YET BEEN ESTABLISHED, AND THE POSITIONAL OF ENDOSCOPIC BILE DUCT STENTING (BILE DUCT STENTING) AND ENDOSCOPIC SPHINCTEROTOMY (EST) AT THE TIME OF EP, WHICH IS THE TOPIC OF THIS ARTICLE, IS ALSO UNCLEAR. IN THIS ARTICLE, BASED ON PREVIOUS REPORTS, THE ROLES OF BILE DUCT STENTING AND EST AFTER EP

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 13790536 ↗
• InjuryJul 27, 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 NURSE THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION USING THE SUBJECT DEVICE, THE DOCTOR USED THE YELLOW PEDAL, WHICH OMSC ESTIMATED THAT IS THE SWITCH OF VIO3 ERBE, TO TAKE OFF A POLYP. THE PATIENT JERKED IMMEDIATELY AND SAID SHE FELT LIKE AN ELECTRIC SHOCK. THE DOCTOR FINISHED CUTTING OFF THE POLYP. THEN, THEY CHANGED THE SNARE FROM 15MM TO A 10MM OLYMPUS SNARE BECAUSE THEY TOOK OFF ANOTHER POLYP. THE NURSE THOUGHT THAT THE SNARES MIGHT BE AT FAULT. THE ENGINEER FROM ERBE CAME THE NEXT DAY AFTER THE INCIDENT AND FOUND NO FAULT WITH THE MACHINE. THE PATIENT WAS RE-ADMITTED AFTER THE PROCEDURE DUE TO A POST POLYPECTOMY BLEEDING, BUT THE NURSE SAID IT WAS NOT DUE TO THIS INCIDENT AS THE PATIENT HAD A LOT OF POLYPS REMOVED.

  Patient problems: Electric Shock

  MAUDE report 12230158 ↗

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-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-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-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.