Single Use Electrosurgical Snare SD-400 SD-400U-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170408250), received between May 4, 2022 and Aug 23, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 6, 2025Class IIOpen, Classified

   Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.

   Z-0483-2026 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED BLOODY STOOLS AFTER A LOW-POWER PURE-CUT HOT SNARE POLYPECTOMY (LPPC HSP). THE DEVICE WAS USED WITH NO INTRAOPERATIVE BLEEDING AND NO CLIP CLOSURE. THE PATIENT HAD ANGINA PECTORIS AND WAS TAKING ASPIRIN ORALLY, WHICH WAS DISCONTINUED 3 DAYS BEFORE TREATMENT AND SCHEDULED TO BE RESUMED THE NEXT DAY. BLOODY STOOL WAS OBSERVED FROM THE EVENING OF THE TREATMENT DAY, AND ALTHOUGH THE PATIENT WAS INSTRUCTED TO POSTPONE THE RESUMPTION OF ASPIRIN, THE BLOODY STOOL CONTINUED UNTIL POST-OP DAY 3 (POD3). ON POD3, AFTER PRETREATMENT, A COLONOSCOPY WAS PERFORMED, AND EXPOSED BLOOD VESSELS EQUIVALENT TO FORREST CLASSIFICATION IIA WERE FOUND AT THE ULCER BASE AFTER LPPC HSP. IT WAS DETERMINED THAT THE POST-BLEEDING WAS DUE TO LPPC HSP, AND CLIP CLOSURE WAS PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20055422 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Respiratory Problem

  MAUDE report 19455304 ↗
• InjuryMar 14, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN PERFORMING A COLD POLYPECTOMY ON A POLYP WITH A LESION SIZE OF 5 MM ("COLD CUT" -THERAPEUTIC PROCEDURE) IN THE LARGE INTESTINE, THE POLYP COULD NOT BE DETACHED/TORN WHEN IT WAS STRANGLED WITH A SINGLE USE ELECTROSURGICAL SNARE. DUE TO THE INABILITY TO PERFORM POLYPECTOMY, THE PROCEDURE WAS CHANGED TO "EMR PROCEDURE" AND THE POLYP WAS MECHANICALLY EXCISED WHICH COULD THEN BE REMOVED FROM THE TISSUE ("THE TREATMENT WAS PERFORMED BY LOCALLY INJECTING IT INTO THE TREATMENT AREA WITHOUT USING HIGH FREQUENCY") THE PROCEDURE WAS EXTENDED; HOWEVER, THE DELAY IS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE. NO ADDITIONAL MEDICATION WAS GIVEN TO THE PATIENT NO REPORTS OF HEALTH HAZARDS TO THE PATIENT. FUTHER PROCEDURAL DETAILS AND OUTCOME OF PATIENT WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908881 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF COLD SNARE POLYPECTOMY OF COLORECTAL POLYPS 10-15 MM WITH A HYBRID SNARE: A PROSPECTIVE OBSERVATIONAL PILOT STUDY". THIS PROSPECTIVE SINGLE-CENTER FEASIBILITY TRIAL EVALUATED THE EFFICACY AND SAFETY OF CSP WITH A HYBRID SNARE IN POLYPS (ADENOMAS AND SSL) WITH A SIZE OF 10¿15 MM. A TOTAL OF 39 PATIENTS WITH 61 ADENOMATOUS POLYPS OR SSL WERE INCLUDED. CSP WAS FEASIBLE IN 78.7% (48/61) OF POLYPS AND THE CRR IN THIS GROUP WAS 85.4% (41/48). WHEN CSP FAILED (13/61; 21.3%), LESIONS WERE SUCCESSFULLY RESECTED USING IMMEDIATE HSP WITH THE SAME SNARE WITH A CRR OF 61.5% (8/13) IN THIS GROUP. EN BLOC RESECTION RATE BY CSP WAS 81.3% (39/48) AND 69.2% (9/13) FOR HSP, RESPECTIVELY. THE OVERALL EN BLOC RESECTION RATE WAS 78.7% (48/61). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: IMMEDIATE BLEEDING-28 PATIENTS 2.1 AND 3.0 HEMOCLIPS, DELAYED BLEEDING- 1 PATIENT HOSPITALIZATION. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : CF-HQ190L, (B)(6) : SD-400U-15. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18377659 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CAN UNDERWATER ENDOSCOPIC MUCOSAL RESECTION BE AN ALTERNATIVE TO CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS?" LITERATURE SUMMARY OBJECTIVES: UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) IS A SIMPLER PROCEDURE FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS (SNADET) THAN CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR). THIS STUDY AIMED TO EVALUATE WHETHER CEMR CAN BE SUBSTITUTED BY UEMR FOR SNADET IN TERMS OF EFFECTIVENESS, SAFETY, AND LEARNING CURVE. METHODS: A TOTAL OF 157 CONSECUTIVE PATIENTS WITH 203 SNADETS <20 MM IN DIAMETER, INCLUDING 107 LESIONS RESECTED BY CEMR AND 96 LESIONS RESECTED BY UEMR, BETWEEN JANUARY 2019 AND MAY 2023, WERE RETROSPECTIVELY RECRUITED. THE TREATMENT OUTCOMES WERE COMPARED BETWEEN THE CEMR AND UEMR GROUPS. THE RISK FACTORS FOR INCOMPLETE RESECTION BY UEMR WERE ANALYZED USING UNIVARIATE AND MULTIVARIATE ANALYSES. LESIONS IN THE UEMR GROUP WERE DIVIDED CHRONOLOGICALLY INTO FIVE PERIODS; THEREAFTER, THE EN BLOC RESECTION RATE AND PROCEDURE TIME WERE COMPARED. RESULTS: NO SIGNIFICANT DIFFERENCES EXISTED BETWEEN THE CEMR AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18335745 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED BY THE CUSTOMER, THE EVIS EXERA III COLONOVIDEOSCOPE WAS MICROBIOLOGICALLY CULTURED ON (B)(6) 2022, AND TESTED POSITIVE FOR HEAVY GROWTH OF PSEUDOMONAS AERUGINOSA. THE POSITIVE FINDING WENT UNNOTICED, AND THE SCOPE WAS USED ON A TOTAL OF FOURTEEN (14) PATIENTS BETWEEN THE DATES OF (B)(6) 2022, AND (B)(6) 2022. TEN (10) OF THE FOURTEEN (14) PATIENTS THAT THE SCOPE WAS USED ON UNDERWENT A POLYPECTOMY DURING THEIR CLINICAL EXAMINATION AND THEREFORE THE FACILITY WAS CONSIDERING AS TO WHETHER THE PATIENTS WERE PLACED AT A HIGHER INFECTION CONTROL RISK. THE INTENDED COLOSCOPY PROCEDURES WERE COMPLETED UNDER NORMAL ENDOSCOPY CONDITIONS. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE. NO ABNORMALITIES WERE NOTED. THE PATIENTS HAD NO EXTENDED HOSPITAL STAY, HOWEVER DID RECEIVE ADDITIONAL TREATMENT OF POSSIBLE PROPHYLAXIS WITH ANTIBIOTICS. NO PATIENT HARM REPORTED TO DATE. THE FACILITY WAS IN THE PROCESS OF REPORTING THE INCIDENT TO (B)(6) MEDICINES AND MEDICAL DEVICES SAFETY AUTHORITY (MEDSAFE). THE FACILITY SUSPECTED AN ISSUE WITH THE SCOPE (FOR EXAMPLE, BIOFILM), AND WANTED OLYMPUS TO PROVIDE PREVIOUS MICROBIOLOGICAL TESTING DETAILS FROM THE LAST USER OF THE SUBJECT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14698046 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "IMPACT OF SUBMUCOSAL SALINE SOLUTION INJECTION FOR COLD SNARE POLYPECTOMY OF SMALL COLORECTAL POLYPS: A RANDOMIZED CONTROLLED STUDY."     THIS STUDY INVESTIGATED WHETHER SUBMUCOSAL INJECTION OF SALINE SOLUTION HELPS TO ACHIEVE DEEPER RESECTION IN COLD SNARE POLYPECTOMY (CSP). TWO HUNDRED FOURTEEN PATIENTS WERE RANDOMLY ASSIGNED TO THE CSP-SI (N = 107) OR C-CSP (N = 107) GROUP. THE RATE OF COMPLETE MM RESECTION WAS 43.9% IN THE CSP-SI GROUP AND 53.3% IN THE C-CSP GROUP, A STATISTICALLY INSIGNIFICANT DIFFERENCE. THE RATES OF NEGATIVE LATERAL MARGIN AND VERTICAL MARGIN (42.3% AND 56.7%, RESPECTIVELY) IN THE CSP-SI GROUP WERE SIGNIFICANTLY LOWER THAN THOSE (58% AND 76%) IN THE C-CSP GROUP (P=.03 AND P=.006, RESPECTIVELY). THERE WAS NO POLYPECTOMY-RELATED MAJOR BLEEDING OR PERFORATION. SALINE SOLUTION INJECTION INTO THE SUBMUCOSA DID NOT IMPROVE THE RESECTION DEPTH OF CSP OF SMALL COLORECTAL POLYPS, AND THE METHOD RESULTED IN LOWER RATES OF NEGATIVE LATERAL AND VERTICAL MARGINS OF RESECTED LESIONS.     MAJOR DELAYED BLEEDING WAS DEFINED AS HEMATOCHEZIA REQUIRING EMERGENT ENDOSCOPIC HEMOSTASIS WITHIN 2 WEEKS AFTER THE PROCEDURE. EMERGENT ENDOSC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14274183 ↗