Single Use Electrosurgical Snare SD-400 SD-400U-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170408243), received between Jun 20, 2022 and Nov 10, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

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-0482-2026 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 12, 2022Adverse 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15589520 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE FACILITY HAD FOUR (4) PATIENTS WITH POST-POLPECTOMY BLEEDING REQUIRING TREATMENT. PATIENT ONE (1) HAD A POLPECTOMY FOR A PEDUNCULATED POLYP OF THE RECTOSIGMOID HINGE. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT TWO (2) HAD A POLPECTOMY FOR A PEDICLED LEFT COLON POLYP, HERB SCALPEL. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT THREE (3) HAD A POLPECTOMY FOR A CENTIMETRIC PEDICLE POLYP OF THE SIGMOID COLON. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT FOUR (4) HAD A POLPECTOMY FOR A PEDUNCULATED SIGMOID POLYP. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THE PATIENT ALSO HAD A LATE OF BLEEDING WHICH REQUIRED HOSPITALIZATION, DEGLOBULATION AND A NEW ENDOSCOPIC EXAMINATION. THIS EVENT IS CAPTURED IN (B)(6). THE CUSTOMER REPORTED FOUR (4) DIFFERENT PATIENT EVENTS AS FOLLOWS: (B)(6) : PATIENT 1 - SD-400U-10, 21V. (B)(6) : PATIENT 2 - SD-400U-10, 24V. (B)(6) : PATIENT 3 - SD-40

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15126582 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE FACILITY HAD FOUR (4) PATIENTS WITH POST-POLPECTOMY BLEEDING REQUIRING TREATMENT. PATIENT (B)(6) HAD A POLPECTOMY FOR A PEDUNCULATED POLYP OF THE RECTOSIGMOID HINGE. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT (B)(6) HAD A POLPECTOMY FOR A PEDICLED LEFT COLON POLYP, HERB SCALPEL. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT (B)(6) HAD A POLPECTOMY FOR A CENTIMETRIC PEDICLE POLYP OF THE SIGMOID COLON. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT (B)(6) HAD A POLPECTOMY FOR A PEDUNCULATED SIGMOID POLYP. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THE PATIENT ALSO HAD A LATE OF BLEEDING WHICH REQUIRED HOSPITALIZATION, DEGLOBULATION AND A NEW ENDOSCOPIC EXAMINATION. THIS EVENT IS CAPTURED IN (B)(6). THE CUSTOMER REPORTED FOUR (4) DIFFERENT PATIENT EVENTS AS FOLLOWS: (B)(6): PATIENT 1 - SD-400U-10, 21V, (B)(6): PATIENT 2 - SD-400U-10, 24V, (B)(6): PATIENT 3 - SD-400U-10, 24V

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15126461 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE FACILITY HAD FOUR (4) PATIENTS WITH POST-POLPECTOMY BLEEDING REQUIRING TREATMENT. PATIENT ONE (1) HAD A POLPECTOMY FOR A PEDUNCULATED POLYP OF THE RECTOSIGMOID HINGE. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT TWO (2) HAD A POLPECTOMY FOR A PEDICLED LEFT COLON POLYP, HERB SCALPEL. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT THREE (3) HAD A POLPECTOMY FOR A CENTIMETRIC PEDICLE POLYP OF THE SIGMOID COLON. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT FOUR (4) HAD A POLPECTOMY FOR A PEDUNCULATED SIGMOID POLYP. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THE PATIENT ALSO HAD A LATE OF BLEEDING WHICH REQUIRED HOSPITALIZATION, DEGLOBULATION AND A NEW ENDOSCOPIC EXAMINATION. THIS EVENT IS CAPTURED IN (B)(6). THE CUSTOMER REPORTED FOUR (4) DIFFERENT PATIENT EVENTS AS FOLLOWS: (B)(6): PATIENT 1 - SD-400U-10, 21V. (B)(6): PATIENT 2 - SD-400U-10, 24V. (B)(6): PATIENT 3 - SD-400U-

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15126408 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE FACILITY HAD FOUR (4) PATIENTS WITH POST-POLPECTOMY BLEEDING REQUIRING TREATMENT. PATIENT ONE (1) HAD A POLPECTOMY FOR A PEDUNCULATED POLYP OF THE RECTOSIGMOID HINGE. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT TWO (2) HAD A POLPECTOMY FOR A PEDICLED LEFT COLON POLYP, HERB SCALPEL. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT THREE (3) HAD A POLPECTOMY FOR A CENTIMETRIC PEDICLE POLYP OF THE SIGMOID COLON. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THIS EVENT IS CAPTURED IN (B)(6). PATIENT FOUR (4) HAD A POLPECTOMY FOR A PEDUNCULATED SIGMOID POLYP. THE PATIENT HAD AN IMMEDIATE POST-POLYPECTOMY HEMORRHAGE. THE TREATMENT WAS CLIPS. THE PATIENT ALSO HAD A LATE OF BLEEDING WHICH REQUIRED HOSPITALIZATION, DEGLOBULATION AND A NEW ENDOSCOPIC EXAMINATION. THIS EVENT IS CAPTURED IN (B)(6). THE CUSTOMER REPORTED FOUR (4) DIFFERENT PATIENT EVENTS AS FOLLOWS: (B)(6): PATIENT 1 - SD-400U-10, 21V; (B)(6): PATIENT 2 - SD-400U-10, 24V; (B)(6): PATIENT 3 - SD-400U-

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15126396 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "RISK OF DELAYED BLEEDING AFTER HOT SNARE POLYPECTOMY AND ENDOSCOPIC MUCOSAL RESECTION IN THE COLORECTUM WITH CONTINUATION OF ANTICOAGULANTS."     THIS RETROSPECTIVE STUDY EVALUATED THE RISK OF DELAYED BLEEDING AFTER HOT SNARE POLYPECTOMY AND ENDOSCOPIC MUCOSAL RESECTION IN THE COLORECTUM WITH CONTINUATION OF ANTICOAGULANTS. A TOTAL OF 137 PATIENTS (283 LESIONS), CLASSIFIED INTO CONTINUATION GROUP OF 50 PATIENTS (93 LESIONS) AND DISCONTINUATION GROUP OF 87 PATIENTS (190 LESIONS) WERE INCLUDED. COLONOSCOPIES WERE PERFORMED USING STANDARD ENDOSCOPES (TYPE CF-HQ290ZI, CF-HQ290I, PCF-H290ZI, OR PCF-Q260JI; OLYMPUS) AFTER FULL BOWEL PREPARATION AND THE INSTRUMENTS USED FOR RESECTION WERE CAPTIVATORTM (BOSTON SCIENTIFIC), SNAREMASTER PLUS (OLYMPUS), AND DUALOOP (MEDICO¿S HIRATA) AND ALL LESIONS INCLUDED IN THIS STUDY WERE TREATED WITH ELECTROCAUTERY PROCEDURES AND ELECTROSURGICAL UNITS (ERBE ICC 200, SOMO TECHNOLOGY) SET TO 30 W FOR COAGULATION AND CUT MODE. DELAYED BLEEDING OCCURRED IN 12 LESIONS, AND THERE WAS NO SIGNIFICANT DIFFERENCE IN THE INCIDENCE RATES BETWEEN THE CONTINUATION AND THE DISCONTINUATION GROUPS (3.2% VS. 4.7%; P=0.756). LOGI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14748537 ↗