Single Use Electrosurgical Hemostatic Forceps FD-411QRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170251535), received between Mar 14, 2022 and Mar 14, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SUBLINGUAL NITROGLYCERINE SPRAY FACILITATES EFFICIENT SUBMUCOSAL TUNNELING DURING PER ORAL ENDOSCOPIC MYOTOMY-A NONRANDOMIZED TRIAL." LITERATURE SUMMARY: THIS STUDY DESCRIBES A NEW METHOD OF USING SUBLINGUAL NITROGLYCERINE SPRAY DURING SUBMUCOSAL TUNNELING TO FACILITATE THE PROCEDURE. THIS STUDY INCLUDES A COHORT OF 50 PATIENTS WHO WERE DIAGNOSED WITH ACHALASIA CARDIA ON HIGH-RESOLUTION ESOPHAGEAL MANOMETRY. ALL THE PROCEDURES WERE TECHNICALLY FEASIBLE AND SUCCESSFUL WITHOUT ANY MAJOR COMPLICATIONS. ECKHARDT¿S SCORES OF ALL PATIENTS NORMALIZED AFTER THE PROCEDURE. THE MEAN SUBMUCOSAL TUNNELING TIME AND MEAN TIME ACROSS GEJ WERE 36.8±7.9, 14.2±2.9 IN INTERVENTION GROUP (SUBLINGUAL NITROGLYCERINE), AND 50.2±8.9 AND 23.0±3.6 MINUTES IN NONINTERVENTION GROUP, RESPECTIVELY. TIME FOR EACH PROCEDURE WAS SIGNIFICANTLY LESS (P < 0.05) IN PATIENTS WHO WERE GIVEN SUBLINGUAL NITROGLYCERINE. ADVERSE EVENTS: ALL THE PROCEDURES WERE TECHNICALLY SUCCESSFUL WITHOUT ANY LONG-TERM COMPLICATIONS. THERE WAS MINIMAL MUCOSAL INJURY (TYPE 1) IN THREE PATIENTS (INTERVENTION GROUP 1 AND NONINTERVENTION 2) THAT WERE LEFT ALONE WITHOUT ANY CONSEQUENCE. TWO PAT

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

  MAUDE report 20048514 ↗
• MalfunctionNov 22, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS THE USER OPENED THE NEW ELECTROSURGICAL HEMOSTATIC FORCEPS, THE RED CAP NORMALLY ATTACHED TO THE PART WHERE THE A CORD IS CONNECTED WAS NOT ATTACHED. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH SIMILAR EQUIPMENT. NO PATIENT HEALTH HAZARD WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193606 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THREE DAYS AFTER A THERAPEUTIC RECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE HAD BEEN PERFORMED, THE PATIENT CONDITION DETERIORATED AND WHEN A LARGE INTESTINE EXAMINATION WAS PERFORMED, IT WAS DISCOVERED THAT BLOOD HAD ACCUMULATED IN THE INTESTINAL MEMBRANE OF THE LARGE INTESTINE (LOCATION UNKNOWN). IT IS UNKNOWN WHETHER THIS WAS THE CAUSE OF THE DETERIORATION OF THE PATIENT'S CONDITION. NO FURTHER INFORMATION ABOUT ADDITIONAL TREATMENT WAS PROVIDED BUT THE PATIENT'S HOSPITALIZATION PERIOD WAS EXTENDED. THERE WAS NO REPORT OF A MALFUNCTION OF ANY OF THE MEDICAL DEVICES USED DURING THE PROCEDURE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE ELECTROSURGICAL GENERATOR USED IN THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE ELECTROSURGICAL KNIFE USED IN THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE USED IN THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS USED IN THIS EVENT. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16440576 ↗
• InjuryDec 21, 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 "EFFICACY OF THE POCKET-CREATION METHOD WITH A TRACTION DEVICE IN ENDOSCOPIC SUBMUCOSAL DISSECTION FOR RESIDUAL OR RECURRENT COLORECTAL LESIONS". LITERATURE SUMMARY: THIS STUDY AIMED TO COMPARE THE EFFICACY OF THE POCKET-CREATION METHOD (PCM) WITH A TRACTION DEVICE (TD) WITH THAT OF CONVENTIONAL ESD FOR RESIDUAL OR RECURRENT COLORECTAL LESIONS IN 72 PATIENTS. THE PRIMARY ENDPOINTS WERE EN BLOC RESECTION AND R0 RESECTION RATES. EN BLOC RESECTION WAS FEASIBLE IN ALL CASES WITH PCM WITH TD BUT FAILED IN 22% OF CASES OF CONVENTIONAL ESD. THE R0 RESECTION RATES FOR PCM WITH TD AND CONVENTIONAL ESD WERE 97% AND 66%, RESPECTIVELY. DISSECTION WAS SIGNIFICANTLY FASTER IN THE PCM WITH TD GROUP (13.0 VS. 7.9 MM2/MIN). THIS STUDY CONCLUDES THAT THE PCM WITH TD IS AN EFFECTIVE METHOD FOR TREATING RESIDUAL OR RECURRENT COLORECTAL LESIONS AFTER INCOMPLETE RESECTION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [CONTROL GROUP]. PERFORATION-1 PATIENT . POST-PROCEDURAL BLEEDING- 1 PATIENT . [PCM WITH TD GROUP]. PERFORATION-1 PATIENT . POST-PROCEDURAL BLEEDING- 1 PATIENT. SINCE THE LITERATURE DESCRIBED "PCF-Q260J", WE SELECTED "PCF-Q260J

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16031173 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOSCOPIC HAND SUTURING FOR MUCOSAL DEFECT CLOSURE AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION MAY REDUCE THE RISK OF POSTOPERATIVE BLEEDING IN PATIENTS RECEIVING ANTITHROMBOTIC THERAPY¿, PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE KD-650L USED IN THE ESD PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE FD-411QR USED IN THE ESD PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE FG-21L-1 USED IN THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE HX-610-090S USED DURING THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE GIF-2TQ260M USED DURING THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE THROUGH THE SCOPE NEEDLE HOLDER USED DURING THE EHS PROCEDURES. STUDY AIM: ENDOSCOPIC HAND SUTURING (EHS) IS EXPECTED TO DECREASE THE RISK OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BLEEDING BY CLOSING MUCOSAL DEFECTS. THE STUDY INVESTIGATED THE EFFICACY OF EHS AFTER GASTRIC ESD IN PATIENTS WITH ANTITHROMBOTIC AGENTS. STUDY METHOD: PROSPECTIVE SINGLE-ARM TRIAL, PAT

  Patient problems: Bradycardia

  MAUDE report 13763296 ↗