Single Use Electrosurgical Snare SD-400Recalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Single Use Electrosurgical Snare SD-400 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 2
We found 3 models of Single Use Electrosurgical Snare SD-400 by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jul 1, 2020 and Jun 9, 2026 — classified as 32 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (2 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Single Use Electrosurgical Snare SD-400 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 6, 2025Open, 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 ↗
- Oct 6, 2025Open, 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-0482-2026 · Root cause: Packaging · Recall details · FDA record ↗
Most reported Single Use Electrosurgical Snare SD-400 problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Failure to Cut2
- Difficult to Remove1
- Dull, Blunt1
- Failure to Fire1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
Patient problems
- Hemorrhage/Blood Loss/Bleeding29
- No Clinical Signs, Symptoms or Conditions5
- Abdominal Pain1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Diarrhea1
- Gastrointestinal Hemorrhage1
- Melena1
- Perforation1
Single Use Electrosurgical Snare SD-400 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Electrosurgical Snare SD-400 SD-400U-10SNARE, NON-ELECTRICAL1 recall13 reports
- Single Use Electrosurgical Snare SD-400 SD-400U-15SNARE, NON-ELECTRICAL1 recall7 reports
- Single Use Electrosurgical Snare SD-400 SD-400-10SNARE, NON-ELECTRICAL16 reports
Recent Single Use Electrosurgical Snare SD-400 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED, "UTILITY OF PROPHYLACTIC CLIPPING AFTER COLORECTAL COLD SNARE POLYPECTOMY IN PATIENTS ON ORAL ANTITHROMBOTIC AGENTS." LITERATURE SUMMARY BACKGROUND AND AIMS: THERE IS NO CONSENSUS ON THE EFFECTIVENESS OF PROPHYLACTIC CLIPPING AFTER COLONIC COLD SNARE POLYPECTOMY (CSP). THIS STUDY AIMED TO EVALUATE THE UTILITY OF PROPHYLACTIC CLIPPING IN PREVENTING DELAYED BLEEDING (DB) AFTER COLORECTAL CSP IN PATIENTS ON ANTITHROMBOTIC AGENTS. METHODS: WE RETROSPECTIVELY RECRUITED CONSECUTIVE PATIENTS ON ANTITHROMBOTIC AGENTS WHO UNDERWENT COLORECTAL CSP IN (B)(6) HOSPITAL. THE DB RATE WAS COMPARED BETWEEN PATIENTS WITH AND WITHOUT PROPHYLACTIC CLIPPING. RESULTS: THE STUDY INCLUDED 133 PATIENTS (422 POLYPS) REQUIRING PROPHYLACTIC CLIPPING AND 85 PATIENTS (282 POLYPS) NOT REQUIRING PROPHYLACTIC CLIPPING. THERE WERE NO SIGNIFICANT DIFFERENCES IN DB AND HEMATOCHEZIA RATES BETWEEN THE GROUPS. BY WEIGHTED LOGISTIC REGRESSION ANALYSIS, THE ODDS RATIO OF HEMATOCHEZIA WAS 0.557 (95% CONFIDENCE INTERVAL, 0.225-1.378; P = .205) IN PATIENTS WITHOUT CLIPPING COMPARED TO THOSE WITH CLIPPING. THE RATES OF HEMATOCHEZIA AND DB WERE 4% (5 OF 133) AN
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25445115 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED, "UTILITY OF PROPHYLACTIC CLIPPING AFTER COLORECTAL COLD SNARE POLYPECTOMY IN PATIENTS ON ORAL ANTITHROMBOTIC AGENTS." LITERATURE SUMMARY BACKGROUND AND AIMS: THERE IS NO CONSENSUS ON THE EFFECTIVENESS OF PROPHYLACTIC CLIPPING AFTER COLONIC COLD SNARE POLYPECTOMY (CSP). THIS STUDY AIMED TO EVALUATE THE UTILITY OF PROPHYLACTIC CLIPPING IN PREVENTING DELAYED BLEEDING (DB) AFTER COLORECTAL CSP IN PATIENTS ON ANTITHROMBOTIC AGENTS. METHODS: WE RETROSPECTIVELY RECRUITED CONSECUTIVE PATIENTS ON ANTITHROMBOTIC AGENTS WHO UNDERWENT COLORECTAL CSP IN CHIBA UNIVERSITY HOSPITAL. THE DB RATE WAS COMPARED BETWEEN PATIENTS WITH AND WITHOUT PROPHYLACTIC CLIPPING. RESULTS: THE STUDY INCLUDED 133 PATIENTS (422 POLYPS) REQUIRING PROPHYLACTIC CLIPPING AND 85 PATIENTS (282 POLYPS) NOT REQUIRING PROPHYLACTIC CLIPPING. THERE WERE NO SIGNIFICANT DIFFERENCES IN DB AND HEMATOCHEZIA RATES BETWEEN THE GROUPS. BY WEIGHTED LOGISTIC REGRESSION ANALYSIS, THE ODDS RATIO OF HEMATOCHEZIA WAS 0.557 (95% CONFIDENCE INTERVAL, 0.225-1.378; P = .205) IN PATIENTS WITHOUT CLIPPING COMPARED TO THOSE WITH CLIPPING. THE RATES OF HEMATOCHEZIA AND DB WERE 4% (5
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25444611 ↗MalfunctionNov 10, 2025Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE ELECTROSURGICAL SNARE DIDN'T CUT THE POLYP NORMALLY AS A COLD SNARE, THE SNARE FELT DULL. THE REPORTED EVENT OCCURRED DURING A DIAGNOSTIC COLONOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513265 ↗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 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION FOR EARLY GASTRIC NEOPLASMS: A MULTICENTER CASE SERIES STUDY". LITERATURE SUMMARY: SEVERAL CASES HAVE BEEN REPORTED THAT SUGGEST THE EFFICACY OF GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION (GI-EMR) FOR GASTRIC NEOPLASMS. HOWEVER, NO STUDY HAS EVALUATED TREATMENT OUTCOMES OF GI-EMR FOR GASTRIC NEOPLASMS. THIS STUDY AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF GI-EMR FOR EARLY GASTRIC NEOPLASMS. NINE PATIENTS (17 LESIONS) UNDERGOING GASTRIC GI-EMR WERE INCLUDED, WITH A MEDIAN LESION SIZE OF 10MM (INTERQUARTILE RANGE [IQR] 5¿13 MM). ALL LESIONS WERE PROTRUDING OR FLAT ELEVATED. THE MEDIAN PROCEDURE TIME WAS 3 MINUTES (IQR 2¿5) AND EN BLOC RESECTION WAS ACHIEVED IN ALL CASES. AMONG 15 NEOPLASTIC LESIONS, THE R0 RESECTION RATE WAS 86.7% (13/15 LESIONS). ADVERSE EVENTS INCLUDED IMMEDIATE BLEEDING REQUIRING HEMOSTASIS IN TWO CASES, WHICH WAS CONTROLLED ENDOSCOPICALLY. NO DELAYED BLEEDING OR PERFORATION OCCURRED. IN CONCLUSION, GI-EMR MAY BE A SAFE AND EFFECTIVE TREATMENT FOR EARLY, SMALL GASTRIC NEOPLASMS. HOWEVER, DUE TO THE SMALL SAMPLE IN THE PRESENT STUDY, FURTHER INVESTIGATION IS REQUIRED R
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19533412 ↗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 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18986055 ↗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 ↗MalfunctionOct 18, 2023Failure to Cut; Failure to Cut
THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THE THERAPEUTIC PROCEDURE, THE SINGLE-USE ELECTROSURGICAL SNARE DID NOT CAUTERIZE WHEN USED WITH THE ERBE. THE CABLE AND THE ERBE WERE CHANGED, AND THE PROBLEM REMAINED. THE PROCEDURE WAS DELAYED FOR 15 TO 20 MINUTES WHILE TROUBLESHOOTING WAS PERFORMED AND THERE WAS AN EXTENSION OF THE PATIENT'S ANESTHESIA. THERE WAS NOT A CLINICALLY RELEVANT PROLONGATION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. RELATED PATIENT IDENTIFIER: (B)(6). (MODEL: SD-400U-10. SN: (B)(6)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17957717 ↗MalfunctionOct 15, 2023Failure to Fire; Failure to Fire
THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE ELECTROSURGICAL SNARE SD-400 SNARE DID NOT CAUTERIZE WHEN USED WITH THE ELEKTROMEDIZIN GMBH GENERATOR. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED FOR 15-20 MINUTES, WITH PATIENT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM. ASSOCIATED PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17936921 ↗MalfunctionMar 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED TO OLYMPUS WHEN SNARING A LESION WITH SINGLE USE ELECTROSURGICAL SNARE SD-400, THERE WAS A PROBLEM THAT LIQUID FLOWED BACK FROM THE HANDLE PART. THE PROCEDURE WAS COMPLETED WITH A COLD CUT, AND THERE WAS NO HEALTH HAZARD TO THE PATIENT. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, WITH NO DELAY NOTED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569513 ↗InjuryFeb 17, 2023Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED TO OLYMPUS THAT DURING POLYPECTOMY USING THIS ELECTROSURGICAL SYSTEM GENERATOR AND SINGLE USE ELECTROSURGICAL SNARE SD-400, THE USER CANNOT CUT, EVEN STEPPED TWICE WITH 20W. THE EXCISION WAS PERFORMED WITH A PULSE CUT OF 30W HOWEVER, BLEEDING OCCURRED. THE CUSTOMER ATTEMPTED TO STOP THE BLEEDING USING A NON-OLYMPUS DEVICE AT 50W BUT FAILED EVEN AFTER INCREASING THE POWER TO 60W. AFTER THAT, THE POWER WAS INCREASED TO 67W AND BURNT OFF, AND THE BLEEDING WAS STOPPED WITH A CLIP TO COMPLETE THE PROCEDURE. AFTER AN OVERNIGHT STAY, THE PATIENT WAS DISCHARGED. THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND WAS READMITTED. HEMOSTASIS WAS PERFORMED AGAIN WITH A NON-OLYMPUS DEVICE. THE FOLLOWING DAY, THE PATIENT DEVELOPED SYMPTOMS OF DIARRHEA. WHEN INSPECTED, AS REPORTED TO OLYMPUS, PERFORATION HAD OCCURRED DUE TO BAKING. AN OPERATION HAS BEEN PLANNED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE ELECTROSURGICAL SNARE SD-400 USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ELECTROSURGICAL SYSTEM GENERATOR USED IN THE PROCEDURE.
Patient problems: Abdominal Pain; Diarrhea; Gastrointestinal Hemorrhage; Perforation
MAUDE report 16401468 ↗InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED IN THE LITERATURE TITLED ¿COLD VERSUS HOT SNARE RESECTION WITH OR WITHOUT SUBMUCOSAL INJECTION OF 6- TO 15-MM COLORECTAL POLYPS: A RANDOMIZED CONTROLLED TRIAL,¿ ONE PATIENT EXPERIENCED A SERIOUS ADVERSE EVENT AFTER A HOT SNARE RECTION PROCEDURE. BACKGROUND AND AIMS: COLD SNARE RESECTION OF COLORECTAL LESIONS HAS BEEN FOUND TO BE SAFE AND EFFECTIVE FOR AN EXPANDING SET OF COLORECTAL LESIONS. IN THIS STUDY, WE SOUGHT TO UNDERSTAND THE EFFICACY OF SIMPLE COLD SNARE RESECTION AND COLD EMR VERSUS HOT SNARE RESECTION AND HOT EMR FOR COLORECTAL LESIONS 6 TO 15 MM IN SIZE. METHODS: AT 3 U.S. CENTERS, 235 PATIENTS WITH 286 COLORECTAL LESIONS 6 TO 15 MM IN SIZE WERE RANDOMIZED TO COLD SNARING, COLD EMR, HOT SNARING, OR HOT EMR FOR NONPEDUNCULATED COLORECTAL LESIONS 6 TO 15 MM IN SIZE. THE PRIMARY OUTCOME WAS COMPLETE RESECTION DETERMINED BY 4 BIOPSY SAMPLES FROM THE DEFECT MARGIN AND 1 BIOPSY SAMPLE FROM THE CENTER OF THE RESECTION DEFECT. RESULTS: THE OVERALL INCOMPLETE RESECTION RATE WAS 2.4% (95% CONFIDENCE INTERVAL [CI], .8%-7.5%). ALL 7 INCOMPLETELY REMOVED POLYPS WERE 10 TO 15 MM IN SIZE AND REMOVED BY HOT EMR (N Z 4, 6.2%), HOT SNARE (N Z 2, 2.2%), OR COLD EMR (N Z 1, 1
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15589623 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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