Single Use Electrosurgical Hemostatic ForcepsRecalls & reported problems across all models

We found 4 models of Single Use Electrosurgical Hemostatic Forceps by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between May 11, 2018 and Aug 13, 2025 — classified as 76 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (10 reports).

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

Most reported Single Use Electrosurgical Hemostatic Forceps problems

Single Use Electrosurgical Hemostatic Forceps models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Electrosurgical Hemostatic Forceps FD-410LR

  FORCEPS, BIOPSY, ELECTRIC
  46 reports
• Single Use Electrosurgical Hemostatic Forceps FD-412LR

  FORCEPS, BIOPSY, ELECTRIC
  17 reports
• Single Use Electrosurgical Hemostatic Forceps FD-411UR

  FORCEPS, BIOPSY, ELECTRIC
  15 reports
• Single Use Electrosurgical Hemostatic Forceps FD-411QR

  FORCEPS, BIOPSY, ELECTRIC
  10 reports

Recent Single Use Electrosurgical Hemostatic Forceps adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS DID NOT PROVIDE HEMOSTASIS AND THE BLEEDING DID NOT STOP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22794016 ↗
• MalfunctionMay 8, 2025Defective Device; Defective Device

  COMPANY REPRESENTATIVE REPORTED THAT THE SUBJECT DEVICE SEAL IS NO LONGER INTACT. THE ISSUE OCCURRED DURING OUT OF THE BOX FAILURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989846 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY COMPARISON OF SCISSOR-TYPE KNIVES WITH NEEDLE-TYPE KNIVES FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A POST-HOC PROPENSITY SCORE-MATCHED ANALYSIS". BACKGROUND AND AIMS: MANY KNIVES HAVE BEEN DEVELOPED TO IMPROVE THE EFFICACY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF SCISSOR-TYPE KNIVES FOR COLORECTAL ESD COMPARED WITH NEEDLE-TYPE KNIVES. METHODS: WE PERFORMED A POST-HOC PROPENSITY SCORE¿MATCHED ANALYSIS IN AN 11-FACILITY STUDY BETWEEN AUGUST 2013 AND DECEMBER 2018. A TOTAL OF 2330 PATIENTS (2498 LESIONS) WHO UNDERWENT COLORECTAL ESD WERE DIVIDED INTO NEEDLE-TYPE (1923 PATIENTS, 2067 LESIONS) AND SCISSOR-TYPE (407 PATIENTS, 431 LESIONS) KNIFE GROUPS. SHORT-TERM OUTCOMES WERE COMPARED BETWEEN THE 2 GROUPS. RESULTS: TWO-TO-ONE PROPENSITY SCORE-MATCHED ANALYSIS IDENTIFIED 814 (709 PATIENTS) AND 407 (386 PATIENTS) LESIONS IN THE NEEDLE-AND SCISSOR-TYPE KNIFE GROUPS, RESPECTIVELY. THE MEDIAN RESECTION SPEED WAS SIGNIFICANTLY FASTER IN THE NEEDLE-TYPE GROUP (18.3MM2/MIN) THAN IN THE SCISSOR-TYPE GROUP (13.2MM2/MIN, P < .0001), WHEREAS EN-BLOC AND HISTOLOG

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21608174 ↗
• InjuryFeb 19, 2025Output above Specifications; Output above Specifications

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Fever

  MAUDE report 21413296 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLINICAL AUDIT OF ENDOSCOPIC SUB-MUCOSAL DISSECTION PERFORMED FOR COMPLEX LATERAL SPREADING COLORECTAL TUMORS FROM A REGION NON-ENDEMIC FOR COLORECTAL CANCER." LITERATURE SUMMARY: BACKGROUND ENDOSCOPIC RESECTION IS CURRENTLY THE TREATMENT OF CHOICE FOR LATERALLY SPREADING TUMORS (LSTS). ENDOSCOPIC SUB-MUCOSAL DISSECTION (ESD) CAN ACHIEVE HIGHER ENBLOC RESECTION AND R0 RESECTION, ALBEIT AT A SLIGHTLY HIGHER RISK OF COMPLICATIONS. GIVEN SCARCE DATA ON ESD FROM INDIA, WE PERFORMED A RETROSPECTIVE ANALYSIS OF OUR EXPERIENCE WITH COLORECTAL ESD (CR-ESD) TO KNOW ITS CLINICAL EFFICACY AND COMPLICATIONS AS WELL AS TO ASSESS THE LEARNING CURVE OF CR-ESD IN NON-ENDEMIC-AREAS. METHODS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY MAINTAINED DATASHEET PERFORMED. ALL PATIENTS WITH LARGE (>2CM), COMPLEX OR RECURRENT COLORECTAL LST WHO UNDERWENT ESD AT OUR CENTER BETWEEN 2012 AND 2021 WERE INCLUDED IN THE STUDY. VARIOUS BASELINE LESION-RELATED PARAMETERS, PROCEDURE-RELATED PARAMETERS, ENBLOC RESECTION (ER) RATES, R0 MARGINS AND ADVERSE EVENT RATES WERE RETRIEVED. CUSUM ANALYSIS WAS PERFORMED TO CALCULATE THE MINIMUM REQUIRED PROCEDURES

  Patient problems: Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20844450 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NONINFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20791449 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES OF ENDOSCOPIC SUB-MUCOSAL DISSECTION IN LATERALLY SPREADING COLORECTAL POLYPS: A TERTIARY CARE CENTRE EXPERIENCE FROM INDIA". LITERATURE SUMMARY BACKGROUND: ENDOSCOPIC SUB-MUCOSAL DISSECTION (ESD) IS AN ESTABLISHED ENDOSCOPIC MODALITY FOR THE MANAGEMENT OF COLORECTAL POLYPS. HOWEVER, THERE ARE NO STUDIES REGARDING THE OUTCOMES OF ESD FROM INDIA. IN THIS STUDY, WE AIMED AT EVALUATING THE OUTCOMES OF ESD IN PATIENTS WITH ADENOMATOUS POLYPS IN THE COLON AND RECTUM. METHODS: DATA OF CONSECUTIVE PATIENTS WHO UNDERWENT ESD FOR COLORECTAL POLYPS FROM 2018 TO 2021 WERE ANALYZED, RETROSPECTIVELY. THE PRIMARY OUTCOME OF THE STUDY WAS THE TECHNICAL SUCCESS OF ESD. THE SECONDARY OUTCOMES INCLUDED THE RATE OF HISTOLOGICALLY COMPLETE RESECTION (R0), ADVERSE EVENTS AND RECURRENCE. RESULTS: SEVENTY PATIENTS (63.5 YEARS, 60% MALES) UNDERWENT ESD FOR POLYPS IN COLON AND RECTUM. A MAJORITY WERE LOCATED IN RECTUM (80%) AND SIGMOID COLON (15.7%). NARROW BAND CLASSIFICATION OF THE POLYPS WAS JAPANESE NARROW BAND IMAGING EXPERT TEAM (JNET)-2A IN 50 (71.4%) AND JNET-2B IN 13 (18.6%) PATIENTS. ESD WAS TECHNICALLY SUCCESSFUL IN 64 (91.4%) PATIENTS U

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20786084 ↗
• InjuryNov 17, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT THE HEMOSTATIC FORCEPS DID NOT WORK IN THE MIDDLE OF A THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS A HEMOSTASIS UNDERTAKEN DUE TO LESION IN THE WALL OF THE UPPER DIGESTIVE TRACT. THE HEMOSTATIC FORCEPS DID NOT WORK IN THE MIDDLE OF THE PROCEDURE. THE PATIENT EXPERIENCED LOSS OF FLUIDS/BLEEDING AND ANESTHESIA TIME WAS GREATLY EXTENDED. THE PATIENT WAS REPORTED TO HAVE A CARDIAC ISSUE WITH A CARDIAC RHYTHM REGULATING DEVICE (TO REGULATE THE HEART RATE). ALSO, THE LESION WAS SUBJECTED TO DIFFERENT TYPE OF DEVICES TO ENSURE ADEQUATE RESULT. AS SUCH, OTHER NONINVASIVE HEMOSTASIS METHODS WERE USED DUE TO PATIENT'S CONDITION IN CONSULTATION WITH CARDIOLOGY TO COMPLETE THE PROCEDURE SAFELY AT A LATER DATE. REPORTEDLY THE BLEEDING WAS ABLE TO BE CONTROLLED, AND THE INTENDED PROCEDURE WAS CANCELLED AND "RESUMED" AFTER A FEW DAYS. THE PATIENT'S CONDITION IS REPORTED AS "CONTROLLED".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20702260 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SAFETY OF EDOXABAN FOR DELAYED BLEEDING IN GASTROINTESTINAL ENDOSCOPIC PROCEDURES WITH A HIGH RISK OF BLEEDING." THIS STUDY INVESTIGATED THE SAFETY OF GASTROINTESTINAL ENDOSCOPIC PROCEDURES IN PATIENTS TAKING EDOXABAN, A DIRECT ORAL ANTICOAGULANT, FOCUSING ON THE INCIDENCE OF DELAYED BLEEDING DURING THE PERIOPERATIVE PERIOD. CONDUCTED FROM JUNE 2018 TO SEPTEMBER 2021, THE SINGLE-CENTER, OPEN-LABEL STUDY INCLUDED 21 PATIENTS ON EDOXABAN UNDERGOING HIGH-RISK ENDOSCOPY. THE PRIMARY OUTCOME, SEVERE DELAYED BLEEDING (CTCAE GRADES III¿V), OCCURRED IN 14% OF PATIENTS, ALL REQUIRING ENDOSCOPIC HEMOSTASIS. NO CASES OF MILD OR MODERATE DELAYED BLEEDING (CTCAE GRADES I-II) OR THROMBOEMBOLIC EVENTS WERE OBSERVED. SECONDARY OUTCOMES INCLUDED COMPLICATIONS LIKE CHOLANGITIS AND ASPIRATION PNEUMONIA, WHICH WERE CONSERVATIVELY TREATED, AND THE MEDIAN HOSPITAL STAY WAS 8 DAYS. PATIENTS WITH DELAYED BLEEDING HAD HIGHER SYSTOLIC BLOOD PRESSURE AT ADMISSION AND LONGER HOSPITAL STAYS. THE STUDY FOUND THAT THE INCIDENCE OF DELAYED BLEEDING IN THESE PATIENTS WAS ACCEPTABLE, WITH HIGHER SYSTOLIC BLOOD PRESSURE AT ADMISSION ASSOCIATED WITH INCREASED RISK, AL

  Patient problems: Aspiration Pneumonitis; Cholangitis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20678096 ↗
• InjuryOct 22, 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 "TRANSVERSE VERSUS LONGITUDINAL MUCOSAL INCISION DURING POEM FOR ESOPHAGEAL MOTILITY DISORDERS: A RANDOMIZED TRIAL". LONGITUDINAL INCISION IS THE COMMONLY USED INCISION FOR ENTRY INTO THE SUBMUCOSAL SPACE DURING PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL MOTILITY DISORDERS. TRANSVERSE INCISION IS ANOTHER ALTERNATIVE FOR ENTRY AND RETROSPECTIVE DATA SUGGEST IT HAS LESS OPERATIVE TIME AND CHANCE OF GAS-RELATED EVENTS. THIS WAS A SINGLE-CENTER, RANDOMIZED TRIAL CONDUCTED AT A TERTIARY CARE HOSPITAL. PATIENTS UNDERGOING POEM FOR ESOPHAGEAL MOTILITY DISORDERS WERE RANDOMIZED INTO GROUP A (LONGITUDINAL INCISION) AND GROUP B (TRANSVERSE INCISION). THE PRIMARY OBJECTIVE WAS TO COMPARE THE TIME NEEDED FOR ENTRY INTO THE SUBMUCOSAL SPACE. THE SECONDARY OBJECTIVES WERE TO COMPARE THE TIME NEEDED TO CLOSE THE INCISION, NUMBER OF CLIPS REQUIRED TO CLOSE THE INCISION, AND DEVELOPMENT OF GAS-RELATED EVENTS. THE SAMPLE SIZE WAS CALCULATED AS FOR A NON-INFERIORITY DESIGN USING KELSEY METHOD. SIXTY PATIENTS WERE RANDOMIZED (30 IN EACH GROUP). ON COMPARING THE 2 TYPES OF INCISIONS, THERE WAS NO DIFFERENCE IN ENTRY TIME [3 (2, 5)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20501830 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "REBLEEDING RISK OF ACUTE HEMORRHAGIC RECTAL ULCER: A MULTICENTER RETROSPECTIVE STUDY". ACUTE HEMORRHAGIC RECTAL ULCER (AHRU) IS CHARACTERIZED BY SUDDEN, PAINLESS, AND MASSIVE BLEEDING FROM RECTAL ULCERS. TO DATE, FEW STUDIES HAVE ANALYZED THE RISK FACTORS FOR AHRU REBLEEDING. IN THIS STUDY, WE CLARIFIED THE RISK FACTORS OF REBLEEDING AFTER INITIAL HEMOSTASIS OF AHRU THROUGH A MULTICENTER STUDY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE. REBLEEDING (35 CASES). REBLEEDING WAS OBSERVED IN 35 PATIENTS (23%), AND THE MEAN TIME FROM INITIAL BLEEDING TO REBLEEDING WAS 5.2 DAYS. THE MEAN NUMBER OF EPISODES WAS 1.8 TIMES. THE MAXIMUM NUMBER OF REBLEEDING EPISODES EXPERIENCED BY A PATIENT WAS SEVEN. ONE PATIENT WITH REFRACTORY BLEEDING, IN WHOM HEMOSTASIS WAS UNSUCCESSFUL, UNDERWENT EMBOLIZATION. MULTIPLE HEMOSTATIC PROCEDURES WERE PERFORMED ONCE IN 3 PATIENTS (3.6%) USING A COMBINATION OF CLIPS AND HEMOSTATIC FORCEPS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20484626 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE DERIVATION AND EXTERNAL VALIDATION OF A FIBROSIS RISK MODEL FOR COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THIS STUDY AIMED TO DERIVE AND VALIDATE A PREDICTION MODEL TO DETERMINE THE PREOPERATIVE DEGREE OF SUBMUCOSAL FIBROSIS IN COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 309 PATIENTS (AGE: 68 ± 10.9 YEARS) UNDERWENT COLORECTAL ESD. NO FIBROSIS (F0), F1 FIBROSIS, AND F2 FIBROSIS WERE REPORTED IN 196 (63.4%), 70 (22.6%), AND 43 (13.9%) CASES, RESPECTIVELY. COMPLICATIONS WERE EXPERIENCED IN 20 (6.4%) RESECTIONS, 10 (3.2%) BEING PERFORATIONS AND 10 (3.2%) SIGNIFICANT BLEEDING. AFTER DISSECTION, HEMOSTASIS WAS PERFORMED WITH A COAGRASPER WHENEVER NECESSARY, AND DEFECTS WERE CLOSED WITH THROUGH-THE-SCOPE CLIPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION/10 PATIENTS. SIGNIFICANT BLEEDING/10 PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20351642 ↗
• InjurySep 23, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE ELECTROSURGICAL GENERATOR WAS USED IN COMBINATION WITH ELECTROSURGICAL HEMOSTATIC FORCEPS AND THE ELECTRICAL OUTPUT WAS WEAK AND SO HEMOSTASIS COULD NOT BE ACHIEVED. THE FORCEPS WAS REPLACED BY ANOTHER ONE BUT NO IMPROVEMENT IN THE ABILITY TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH A DELAY OF 10-15 MINUTES. FOLLOW-UP IDENTIFIED THAT SALINE WAS SPRAYED TO CLEAR BLEEDING SITE AND DRAIN THE BLOOD AS THE PATIENT WAS BLEEDING A LOT. THE SETTING VALUE OF THE DEVICE WAS NORMAL (¿SAME AS USUAL¿) BUT THE BLEEDING COULD NOT BE STOPPED. AFTER REPLACING WITH ANOTHER FORCEPS, A CABLE CORD FROM ANOTHER MANUFACTURER (A TROUBLESHOOTING MEASURE) AND OTHER SIMILAR DEVICE, THE PROCEDURE WAS ABLE TO BE COMPLETED. THE DEVICE WAS INSPECTED, AND NO ABNORMALITIES WERE FOUND. ALSO, IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE FORCEPS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20280934 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SPRAY COAGULATION REDUCES THE USE OF HEMOSTATIC FORCEPS FOR INTRAOPERATIVE BLEEDING IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THIS STUDY RETROSPECTIVELY ASSESSED THE EFFECTIVENESS OF SPRAY MODES ON INTRAOPERATIVE BLEEDING DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 316 BLEEDING EVENTS (156 IN THE SWIFT GROUP AND 160 IN THE SPRAY GROUP) WERE CONSECUTIVELY RECORDED. IN THE SWIFT GROUP, HEMOSTASIS WAS PERFORMED USING THE SWIFT MODE WITH A RETRACTED TIP OF THE NEEDLE-TYPE KNIFE, FOLLOWED BY THE HEMOSTATIC FORCEPS. IN THE SPRAY GROUP, BLEEDING WAS TREATED IN A STEPWISE MANNER: THE SWIFT MODE, THE SPRAY MODE, AND THE HEMOSTATIC FORCEPS. THE PROCEDURE TIME IN THE SWIFT GROUP AND THE SPRAY GROUP WERE 45 (34¿62) MIN AND 46 (32.5¿61) MIN, RESPECTIVELY. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE TOTAL HEMOSTATIC TIME (SWIFT GROUP, 20 S.; SPRAY GROUP, 16 S.; P = 0.42). IN THE ESD OUTCOMES OF THE SWIFT GROUP AND THE SPRAY GROUP, THE EN BLOC RESECTION RATE (100% VS. 100%), THE R0 RESECTION RATE (100% VS. 97%), AND THE RATE OF CURATIVE RE SECTION (86% VS. 87%) HAD NO SIGNIFICANT DIFFERENCES. DISCUSSION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20272976 ↗
• InjurySep 13, 2024Adverse 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 FACTORS AND A NOMOGRAM FOR PREDICTION OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME FOR SUPERFICIAL COLORECTAL LESIONS". LITERATURE SUMMARY BACKGROUND POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME (PEECS) IS AN UNCOMMON COMPLICATION AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THIS STUDY AIMED TO EXPLORE THE RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS BASED ON THE LATEST AND CONSISTENT DIAGNOSTIC CRITERIA AND TO ESTABLISH A PREDICTIVE NOMOGRAM MODEL. METHODS THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WITH SUPERFICIAL COLORECTAL LESIONS WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN JUNE 2008 AND DECEMBER 2021 IN OUR CENTER. THE INDEPENDENT RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS WERE IDENTIFIED USING LEAST ABSOLUTE SHRINKAGE AND SELECTION OPERATOR (LASSO) LOGISTIC REGRESSION ANALYSIS, AS WELL AS UNIVARIATE ANALYSIS AND MULTIVARIATE LOGISTIC REGRESSION, AND DERIVED PREDICTIVE NOMOGRAM MODEL WAS CONSTRUCTED. RESULTS AMONG THE 555 PATIENTS WITH SUPERFICIAL COLORECTAL LESIONS ENROLLED, PEECS OCCURRED IN 45 (8.1%) P

  Patient problems: Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation; Perforation

  MAUDE report 20214383 ↗

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