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

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170251542), received between Sep 17, 2019 and May 8, 2025 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (3 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, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 13, 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 "BALLOON-ASSISTED ENTEROSCOPY-BASED ENDOSCOPIC STRICTUROTOMY FOR DEEP SMALL BOWEL STRICTURES FROM CROHN'S DISEASE: FIRST COHORT STUDY OF A NOVEL APPROACH". LITERATURE SUMMARY. BACKGROUND: THERE IS LITTLE DATA ON THE ROLE OF ENDOSCOPIC STRICTUROTOMY (ES) IN TREATING DEEP SMALL BOWEL STRICTURES. WE AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF BALLOON-ASSISTED ENTEROSCOPY-BASED ES (BAE- BASED ES) FOR DEEP SMALL BOWEL STRICTURES ASSOCIATED WITH CROHN¿S DISEASE (CD). METHODS: THIS MULTICENTRE RETROSPECTIVE COHORT STUDY INCLUDED CONSECUTIVE PATIENTS WITH CD-ASSOCIATED DEEP SMALL BOWEL STRICTURES TREATED WITH BAE-BASED ES BETWEEN 2017 AND 2023. THE OUTCOMES INCLUDED TECHNICAL SUCCESS, CLINICAL IMPROVEMENT, SURGERY-FREE RATE, REINTERVENTION-FREE RATE, AND ADVERSE EVENTS. RESULTS: TWENTY-EIGHT PATIENTS WITH CD UNDERWENT 58 BAE-BASED ES PROCEDURES FOR NON-PASSABLE DEEP SMALL BOWEL STRICTURES, WITH A MEDIAN FOLLOW-UP TIME OF 519.5 DAYS (INTERQUARTILE RANGE, 306¿728 DAYS). FIFTY-SIX (96.0%) PROCEDURES WERE TECHNICALLY SUCCESSFUL IN 26 (92.9%) PATIENTS. TWENTY PATIENTS (71.4%) SHOWED CLINICAL IMPROVEMENT AT WEEK 8. THE CUMULAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18123357 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT ACCORDING TO THE AUTHOR, THERE WAS NO PROBLEM RELATED TO THE OLYMPUS DEVICE.

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

  MAUDE report 17922968 ↗
• MalfunctionMar 9, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THE SUBJECT DEVICE WAS USED BEYOND THE EXPIRY DATE OF 31MAR2020. THE ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE WAS COMPLETED SMOOTHLY AND SUCCESSFULLY AND THE PATIENT WAS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511874 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS RECEIVED: THE AUTHORS DECLARE THAT THEY HAVE NOTHING TO DISCLOSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16400755 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF COLONIC NEOPLASTIC LESIONS = 30 MM¿A SINGLE-CENTER EXPERIENCE."    LITERATURE SUMMARY: THE PURPOSE OF THE ANALYSIS WAS TO EVALUATE EFFICACY AND SAFETY OF FULL-THICKNESS RESECTION (FTR) IN THE TREATMENT OF COLORECTAL LESIONS = 30 MM BY COMPARING PROSPECTIVELY FOLLOWED FTR COHORT TO RETROSPECTIVE SUBMUCOSAL DISSECTION (ESD) COHORT IN THE SETTING OF SINGLE TERTIARY ENDOSCOPY CENTER. PRIMARY OUTCOMES WERE TECHNICAL SUCCESS RATE, R0 RESECTION AND CURATIVE RESECTION RATE, AND COMPLICATION RATE. A TOTAL OF 52 PATIENTS IN FTR AND 50 PATIENTS IN ESD GROUP WERE TREATED BETWEEN 2015 AND 2018. TECHNICAL SUCCESS RATE WAS SIGNIFICANTLY HIGHER IN FTR GROUP (92 VS. 74%, P = 0.01) AS WELL AS R0 RESECTION RATE (85 VS. 62%, P = 0.01) AND CURATIVE RESECTION RATE (75 VS. 56%, P = 0.01). COMPLICATIONS OCCURRED MORE FREQUENTLY IN ESD GROUP (40 VS. 13%, P = 0.002), MAINLY DUE TO HIGH INCIDENCE OF ELECTROCOAGULATION SYNDROME (24 VS. 0%). TOTAL PROCEDURE TIME WAS SUBSTANTIALLY SHORTER IN FTR GROUP (26.4 ± 11.0 MIN VS. ESTIMATED 90¿240 MIN). LOCAL RESIDUAL NEOPLASTIC LES

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

  MAUDE report 14856860 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "PROPENSITY SCORE MATCHING ANALYSIS TO EVALUATE EFFICACY OF POLYETHYLENE OXIDE ADHESIVE ON PREVENTING DELAYED BLEEDING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION" BY YANG YU, ET AL.   REGARDLESS OF TECHNICAL ADVANCEMENTS, DELAYED BLEEDING IS STILL A COMMON ADVERSE EVENT AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), OFTEN OCCURRING IN THE EARLY POSTOPERATIVE PHASE. THIS STUDY AIMED TO EVALUATE THE EFFICACY OF A NEWLY DESIGNED POLYETHYLENE OXIDE (PEO) ADHESIVE FOR PREVENTING DELAYED GASTRIC BLEEDING. PATIENTS WHO UNDERWENT GASTRIC ESD BETWEEN DECEMBER 2017 AND DECEMBER 2020 AT THREE CHINESE INSTITUTIONS WERE RETROSPECTIVELY REVIEWED. PATIENTS RECEIVING PEO APPLICATION ON GASTRIC POST-ESD ULCERS WERE INCLUDED IN THE PEO GROUP, AND PATIENTS WITHOUT THIS PROCEDURE WERE INCLUDED IN THE CONTROL GROUP. TO MINIMIZE POTENTIAL BIAS, PROPENSITY SCORE MATCHING WAS PERFORMED, AND SEX, AGE, LESION SIZE, LESION MORPHOLOGY, ULCERATION, LOCALIZATION, PROCEDURE TIME, FREQUENCY OF MAJOR INTRAOPERATIVE BLEEDING, RESECTED SPECIMEN SIZE, LESION HISTOPATHOLOGY, SUBMUCOSAL INVASION AND THE TAKING OF ANTITHROMBOTIC DRUGS WERE INCLUDED AS MATCHIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 14103866 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ENDOLUMINAL VACUUM CLOSURE OF A DUODENAL PERFORATION¿, A PATIENT EXPERIENCED PERFORATION ON POST-OPERATIVE DAY ONE AFTER CLOSURE OF A MUCOSAL DEFECT (USING AN OLYMPUS COAGRASPER, AND 12 QUICKCLIP PRO ENDOCLIPS) CAUSED BY AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: COAGRASPER CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: QUICKCLIP PRO ENDOCLIPS. THIS LITERATURE WAS A CASE REPORT OF ONE PATIENT WHO UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. THIS WAS COMPLICATED BY INTRA-PROCEDURAL BLEEDING OF 250ML BLOOD LOSS. BLOOD LOSS WAS STOPPED WITH THE USE OF EPINEPHRINE INJECTION, AND A COAGRASPER. THE MUCOSAL DEFECT WAS THEN CLOSED WITH 12 QUICKCLIP PRO ENDOCLIPS. THE PATIENT DEVELOPED EVIDENCE OF PERFORATION ON POST-OPERATIVE DAY ONE. THE PATIENT WAS TAKEN BACK TO SURGERY ON THIS DAY AND THE AREA WAS IRRIGATED AND WIDELY DRAINED. PERFORATION CLOSURE WAS NOT ATTEMPTED AT THIS TIME DUE TO SEVERE THICKENING AN

  Patient problems: Perforation

  MAUDE report 13424029 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOLUMINAL VACUUM CLOSURE OF A DUODENAL PERFORATION¿, A PATIENT EXPERIENCED PERFORATION ON POST-OPERATIVE DAY ONE AFTER CLOSURE OF A MUCOSAL DEFECT (USING AN OLYMPUS COAGRASPER, AND 12 QUICKCLIP PRO ENDOCLIPS) CAUSED BY AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: COAGRASPER. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: QUICKCLIP PRO ENDOCLIPS. THIS LITERATURE WAS A CASE REPORT OF ONE PATIENT WHO UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. THIS WAS COMPLICATED BY INTRA-PROCEDURAL BLEEDING OF 250ML BLOOD LOSS. BLOOD LOSS WAS STOPPED WITH THE USE OF EPINEPHRINE INJECTION, AND A COAGRASPER. THE MUCOSAL DEFECT WAS THEN CLOSED WITH 12 QUICKCLIP PRO ENDOCLIPS. THE PATIENT DEVELOPED EVIDENCE OF PERFORATION ON POST-OPERATIVE DAY ONE. THE PATIENT WAS TAKEN BACK TO SURGERY ON THIS DAY AND THE AREA WAS IRRIGATED AND WIDELY DRAINED. PERFORATION CLOSURE WAS NOT ATTEMPTED AT THIS TIME DUE TO SEVERE THICKENING

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Scar Tissue

  MAUDE report 13424011 ↗
• InjuryJul 12, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED, ¿WE HAVE EXPERIENCED PROBLEMS WITH THE COAGRASPER, LACK OF CURRENT WHEN APPLIED TO A VESSEL. IN ONE SITUATION THE PRODUCT WORKED ON ANOTHER ERBE UNIT. IN ANOTHER SITUATION THE PRODUCT DID NOT WORK ON 2 DIFFERENT ERBE UNITS. (UNFORTUNATELY LOT NUMBERS WERE NOT KEPT) BIO SERVE HAVE CONFIRMED CORRECT ERBE SETTINGS.¿ OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED ON (B)(6) 2021 THAT THEY HAD A CASE LAST WEEK WHERE A PATIENT NEEDED ADMISSION AS THE COAGRASPERS WERE NOT WORKING. IT WAS A LARGE POLYP THAT BLED ON THE FIRST CUT. CLIPPING IT DISTORTS THE BASE AND THEY WOULDN¿T HAVE BEEN ABLE TO GET THE REST OFF. THEY KEPT THE PATIENT IN A POSITION THAT GRAVITY WOULD DRAIN THE BLOOD AWAY FROM THE DEFECT SO THEY COULD KEEP RESECTING THE POLYP. THE SURGEON CLIPPED IT POST POLYPECTOMY, BUT IT HAD BLED FOR OVER AN HOUR AT THAT POINT SO THE PATIENT WAS ADMITTED OVERNIGHT. THE PATIENT WAS FINE IN THE END BUT IF COAGRASPERS COULD BE WORK, THE SURGEON COULD HAVE STOPPED IT STRAIGHT AWAY. THE PATIENT HAD A LOOPY SIGMOID WHICH MADE THE PROCEDURE DIFFICULT AS PULLING BACK TO WHERE THE POLYP WAS OFTEN MEANT THE LOOP REFORMED AND THE SCOPE SLIPPED BACK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12148520 ↗
• MalfunctionJan 21, 2020Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE SUBJECT DEVICE DID NOT ACTIVATE OUTPUT WHEN STEPPED ON THE FOOT SWITCH. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS DISCARDED BY THE USER. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE FAILURE OF THE OUTPUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9614136 ↗
• MalfunctionJan 14, 2020Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION, THE SUBJECT DEVICES WAS USED. IN THE PROCEDURE, THE USER GRASPED THE TISSUE AND ACTIVATED THE FOOT PEDAL BUT THE SUBJECT DEVICE DID NOT ACTIVATE OUTPUT. THE USER TRIED NEW CORDS AND MADE SURE THE SETTING WAS CORRECT ON THE MACHINE. HOWEVER, IT WAS NOT REPORTED HOW THE INTENDED PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THE SUBJECT DEVICE WAS DISCARDED BY THE USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584836 ↗
• MalfunctionSep 17, 2019Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE SUBJECT DEVICE DID NOT ACTIVATE OUTPUT FOR THE COAGULATION WHILE THE BISTOURY WORKED WELL WITH OTHER MEDICAL DEVICES. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE FAILURE OF THE OUTPUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079979 ↗