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

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170396694), received between Jul 1, 2020 and Jun 9, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "REPEAT COLD SNARE POLYPECTOMY CAN BE PERFORMED FOR RECURRENT BENIGN LESIONS AFTER COLD SNARE POLYPECTOMY" THIS RETROSPECTIVE STUDY AIMED TO ANALYZE RECURRENCE AFTER COLD SNARE POLYPECTOMY (CSP) SOMETIMES OCCURS AND ASSESSED THE FEASIBILITY OF REPEAT CSP FOR RECURRENCE AFTER CSP. AMONG 324 PATIENTS, 48 PATIENTS WERE REPEAT CSP GROUP AND 276 PATIENTS WERE STANDARD CSP GROUP. REGARDING THE COMPARISON OF REPEAT CSP/ STANDARD CSP GROUP, THE EN BLOC RESECTION AND HISTOPATHOLOGICAL COMPLETE RESECTION RATES WERE 63/ 445 AND 35/271 AND THE RATES OF PERIOPERATIVE HEMORRHAGE REQUIRING ENDOSCOPIC CLIPPING WERE 1/ 5. THERE WERE NO POSTOPERATIVE HEMORRHAGE AND PERFORATION IN BOTH GROUPS. THIS STUDY CONCLUDED THAT REPEAT CSP FOR RECURRENT LESIONS WAS QUICK, SAFE, AND FEASIBLE AS A PILOT STUDY OF SMALL SAMPLE SIZE. THE RECURRENCE RATE OF REPEAT CSP WAS NOT HIGHER THAN STANDARD CSP THOUGH THE RATE OF HISTOPATHOLOGICAL COMPLETE RESECTION WAS LOWER THAN IT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [REPEAT CSP GROUP] (N=48). PERIOPERATIVE BLEEDING - 1 PATIENT. [STANDARD CSP GROUP] (N= 276). PERIOPERATIVE BLEEDING - 5 PATIENTS. THIS LITERATURE ARTICLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15491384 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "RISK OF DELAYED BLEEDING AFTER COLD SNARE POLYPECTOMY IN PATIENTS WITH ANTITHROMBOTIC THERAPY." LITERATURE SUMMARY: THIS STUDY AIMED TO INVESTIGATE THE REAL-WORLD SAFETY OF COLD SNARE POLYPECTOMY DURING ANTITHROMBOTIC THERAPY. BASED ON THE COLLECTED DATA FROM CONSECUTIVE PATIENTS UNDERGOING COLD SNARE POLYPECTOMY IN A SINGLE HOSPITAL BETWEEN 2013 AND 2017. INDICATIONS FOR COLD SNARE POLYPECTOMY WERE ANY = 10 MM POLYP. THE PRIMARY OUTCOME WAS DELAYED BLEEDING. THIS WAS COMPARED RATES OF DELAYED BLEEDING BETWEEN PATIENT WITH AND WITHOUT ANTITHROMBOTIC THERAPY AND ANALYZED RISK FACTORS FOR DELAYED BLEEDING USING BINARY LOGISTIC REGRESSION MODEL WITH FIRTH PROCEDURE. DELAYED BLEEDING OCCURRED IN 11 PATIENTS OUT OF 2, 152 PATIENTS. THE RATE OF DELAYED BLEEDING WAS HIGHER IN PATIENTS ON ANTITHROMBOTIC THERAPY. PATIENTS ON ANTITHROMBOTIC THERAPY WERE OLDER MORE LIKELY MALE PATIENTS AND HAD COLD SNARE POLYPECTOMY. LARGER POLYPS¿ SIZE (>5MM), USE OF CLIPS AND ANTITHROMBOTIC THERAPY WERE SIGNIFICANT RISK FACTORS FOR DELAYED BLEEDING. HOWEVER, THERE WAS NO CLEAR ASSOCIATION BETWEEN SPECIFIC ANTITHROMBOTIC AGENTS AND DELAYED BL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13962208 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "RISK OF DELAYED BLEEDING AFTER COLD SNARE POLYPECTOMY IN PATIENTS WITH ANTITHROMBOTIC THERAPY". LITERATURE SUMMARY: THIS STUDY AIMED TO INVESTIGATE THE REAL-WORLD SAFETY OF COLD SNARE POLYPECTOMY DURING ANTITHROMBOTIC THERAPY. BASED ON THE COLLECTED DATA FROM CONSECUTIVE PATIENTS UNDERGOING COLD SNARE POLYPECTOMY IN A SINGLE HOSPITAL BETWEEN 2013 AND 2017. INDICATIONS FOR COLD SNARE POLYPECTOMY WERE ANY = 10 MM POLYP. THE PRIMARY OUTCOME WAS DELAYED BLEEDING. THIS WAS COMPARED RATES OF DELAYED BLEEDING BETWEEN PATIENT WITH AND WITHOUT ANTITHROMBOTIC THERAPY AND ANALYZED RISK FACTORS FOR DELAYED BLEEDING USING BINARY LOGISTIC REGRESSION MODEL WITH FIRTH PROCEDURE. DELAYED BLEEDING OCCURRED IN 11 PATIENTS OUT OF 2, 152 PATIENTS. THE RATE OF DELAYED BLEEDING WAS HIGHER IN PATIENTS ON ANTITHROMBOTIC THERAPY. PATIENTS ON ANTITHROMBOTIC THERAPY WERE OLDER MORE LIKELY MALE PATIENTS AND HAD COLD SNARE POLYPECTOMY. LARGER POLYPS¿ SIZE (>5MM), USE OF CLIPS AND ANTITHROMBOTIC THERAPY WERE SIGNIFICANT RISK FACTORS FOR DELAYED BLEEDING. HOWEVER, THERE WAS NO CLEAR ASSOCIATION BETWEEN SPECIFIC ANTITHROMBOTIC AGENTS AND DELAYED BL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13962029 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "RISK OF DELAYED BLEEDING AFTER COLD SNARE POLYPECTOMY IN PATIENTS WITH ANTITHROMBOTIC THERAPY". LITERATURE SUMMARY: THIS STUDY AIMED TO INVESTIGATE THE REAL-WORLD SAFETY OF COLD SNARE POLYPECTOMY DURING ANTITHROMBOTIC THERAPY. BASED ON THE COLLECTED DATA FROM CONSECUTIVE PATIENTS UNDERGOING COLD SNARE POLYPECTOMY IN A SINGLE HOSPITAL BETWEEN 2013 AND 2017. INDICATIONS FOR COLD SNARE POLYPECTOMY WERE ANY = 10 MM POLYP. THE PRIMARY OUTCOME WAS DELAYED BLEEDING. THIS WAS COMPARED RATES OF DELAYED BLEEDING BETWEEN PATIENT WITH AND WITHOUT ANTITHROMBOTIC THERAPY AND ANALYZED RISK FACTORS FOR DELAYED BLEEDING USING BINARY LOGISTIC REGRESSION MODEL WITH FIRTH PROCEDURE. DELAYED BLEEDING OCCURRED IN 11 PATIENTS OUT OF 2, 152 PATIENTS. THE RATE OF DELAYED BLEEDING WAS HIGHER IN PATIENTS ON ANTITHROMBOTIC THERAPY. PATIENTS ON ANTITHROMBOTIC THERAPY WERE OLDER MORE LIKELY MALE PATIENTS AND HAD COLD SNARE POLYPECTOMY. LARGER POLYPS¿ SIZE (>5MM), USE OF CLIPS AND ANTITHROMBOTIC THERAPY WERE SIGNIFICANT RISK FACTORS FOR DELAYED BLEEDING. HOWEVER, THERE WAS NO CLEAR ASSOCIATION BETWEEN SPECIFIC ANTITHROMBOTIC AGENTS AND DELAYED BL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13961991 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "RISK OF DELAYED BLEEDING AFTER COLD SNARE POLYPECTOMY IN PATIENTS WITH ANTITHROMBOTIC THERAPY". LITERATURE SUMMARY: THIS STUDY AIMED TO INVESTIGATE THE REAL-WORLD SAFETY OF COLD SNARE POLYPECTOMY DURING ANTITHROMBOTIC THERAPY. BASED ON THE COLLECTED DATA FROM CONSECUTIVE PATIENTS UNDERGOING COLD SNARE POLYPECTOMY IN A SINGLE HOSPITAL BETWEEN 2013 AND 2017. INDICATIONS FOR COLD SNARE POLYPECTOMY WERE ANY = 10 MM POLYP. THE PRIMARY OUTCOME WAS DELAYED BLEEDING. THIS WAS COMPARED RATES OF DELAYED BLEEDING BETWEEN PATIENT WITH AND WITHOUT ANTITHROMBOTIC THERAPY AND ANALYZED RISK FACTORS FOR DELAYED BLEEDING USING BINARY LOGISTIC REGRESSION MODEL WITH FIRTH PROCEDURE. DELAYED BLEEDING OCCURRED IN 11 PATIENTS OUT OF 2, 152 PATIENTS. THE RATE OF DELAYED BLEEDING WAS HIGHER IN PATIENTS ON ANTITHROMBOTIC THERAPY. PATIENTS ON ANTITHROMBOTIC THERAPY WERE OLDER MORE LIKELY MALE PATIENTS AND HAD COLD SNARE POLYPECTOMY. LARGER POLYPS¿ SIZE (>5MM), USE OF CLIPS AND ANTITHROMBOTIC THERAPY WERE SIGNIFICANT RISK FACTORS FOR DELAYED BLEEDING. HOWEVER, THERE WAS NO CLEAR ASSOCIATION BETWEEN SPECIFIC ANTITHROMBOTIC AGENTS AND DELAYED BL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13961907 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10) HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953621 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10) HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953619 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10) HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953610 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10). HOT SNARE POLYPECTOMY (HSP) GROUP: CASE WITH PATIENT IDENTIFIER (B)(6)-REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953595 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10). HOT SNARE POLYPECTOMY (HSP) GROUP CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953547 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE TITLED ¿RISK FACTORS OF DELAYED BLEEDING AFTER COLD SNARE POLYPECTOMY FOR COLORECTAL POLYPS: A MULTICENTER STUDY,¿ PATIENTS EXPERIENCED DELAYED BLEEDING (DB) AFTER COLD SNARE POLYPECTOMY (CSP) PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AZI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290I. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290ZI. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-HQ290I. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SD-210L-10. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SD-400U-10. STUDY BACKGROUND/AIM: DELAYED BLEEDING (DB) RARELY OCCURS AFTER COLD SNARE POLYPECTOMY (CSP) FOR COLORECTAL POLYPS, BUT NO LARGE-SCALE STUDIES HAVE INVESTIGATED THIS. THE STUDY EVALUATED THE RATE, CHARACTERISTICS, AND RISK FACTORS OF DB OF CSP. METHODS: A MULTICENTER RETROSPECTIVE STUDY AT 10 JAPANESE INSTITUTIONS. A TOTAL OF 18,007 PATIENTS UNDERWENT CSP FOR COLORECTAL POLYPS = 10 MM IN SIZE FROM MARCH 2015 TO SEPTEMBER 2019, AND CASES OF DB (DB GROUP) WERE ANALYZED FOR THE RATE, ANTITHROMBOTIC DRUGS, POLYP SIZE, MORPHOLOGY, LOCATION, AND RISK FACTORS. AS A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13949622 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 25, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "MANAGEMENT OF LESS THAN 10-MM-SIZED PEDUNCULATED (IP) POLYPS WITH THIN STALK: HOT SNARE POLYPECTOMY VERSUS COLD SNARE POLYPECTOMY¿. THE PURPOSE OF THE LITERATURE WAS TO EVALUATE WHETHER THE RATE OF DELAYED POSTPOLYPECTOMY BLEEDING (DPPB) AFTER COLD SNARE POLYPECTOMY (CSP) FOR IP POLYPS WAS HIGHER THAN THAT AFTER SNARE POLYPECTOMY (HSP) FOR IP POLYPS AND COMPARED OTHER OUTCOMES (THE RATES OF IMMEDIATE BLEEDING AND PATHOLOGICAL MARGINS) BETWEEN THE HSP AND CSP PROCEDURES. THE HSP AND CSP WAS PERFORMED USING A SNARE (SNAREMASTER-PLUS OR SNAREMASTER: OLYMPUS) AND AN ENDOSCOPY (CF-H260AZI, PCF-Q260AZI, PCF-Q290AZI, OR PCF-H290ZI: OLYMPUS). SNARE CATHETER WAS MANUFACTURED BY UNKNOWN. IN THE LITERATURE, IT WAS REPORTED 3 IMMEDIATE BLEEDINGS AND 4 DPPBS IN HSP, AND 39 IMMEDIATE BLEEDINGS IN CSP. DPPB WAS DEFINED AS A FALL IN HEMOGLOBIN LEVEL BY AT LEAST 2 G/DL BELOW THE MOST RECENT PREOPERATIVE LEVEL OR THE NEED FOR ENDOSCOPIC HEMOSTASIS AND/OR BLOOD TRANSFUSION AND/OR MASSIVE MELENA. IMMEDIATE BLEEDING THAT NECESSITATED HEMOSTATIC CLIPPING WAS DEFINED AS SPURTING OR OOZING THAT CONTINUED FOR MORE THAN 30 S. THE L

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Melena

  MAUDE report 12826236 ↗
• InjuryJul 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿COLD SNARE PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION OF LARGE SESSILE COLONIC POLYPS =20 MM (WITH VIDEO)¿. THE LITERATURE REPORTED THE RESULT OF 186 PATIENTS OF THE COLD SNARE PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION (CSP-EMR) PROCEDURE USING OLYMPUS SINGLE USE ELECTROSURGICAL SNARE SD-400U-10 OR NON-OLYMPUS REF-00711115 (US ENDOSCOPY) FROM JANUARY 2016 TO DECEMBER 2017. IN THE SUBJECT CASES, 7 CASES OF CLINICALLY SIGNIFICANT POST-EMR BLEEDING OCCURRED. THERE WAS NO INFORMATION ON WHICH MODEL WAS USED IN WHICH PROCEDURE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THEREFORE, OMSC WILL SUBMIT A MEDICAL DEVICE REPORTS (MDR) DEPENDING ON THE TYPE OF ADVERSE EVENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10222329 ↗