Olympus WB991036Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04042768910364), received between Sep 29, 2020 and May 15, 2026 — classified as 21 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Output Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Display or Visual Feedback Problem; Energy Output Problem; No Audible Prompt/Feedback

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Bowel Burn; Bowel Perforation; Gastrointestinal Hemorrhage

  MAUDE report 25185176 ↗
• MalfunctionApr 6, 2026Communication or Transmission Problem

  THE GENERATOR WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE CONTACT PLATE WAS NOT WORKING. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE RETURN ELECTRODE CABLE LOOSE AND AN ERROR E232 WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789375 ↗
• MalfunctionApr 3, 2026Communication or Transmission Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR HAD AN E232 ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779569 ↗
• InjuryJan 2, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURES, THE SETTINGS OF THIS ELECTROSURGICAL GENERATOR WERE JUMPING ACROSS PROFILES. THE USER FELT AS IF THE "CUT WAS TOO HARSH" AND "THE COAG WAS SHARP". IT WAS NOTED THAT THERE WAS AN INCREASE IN "SPENTROTAMY" BLEEDS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE OCCURRENCES OF BLEEDING WERE DETECTED AFTER THE PROCEDURE. THERE WAS SIGNIFICANT BLEEDING IN AT LEAST TWO PATIENTS NECESSITATING BLOOD TRANSFUSION AND INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION IN ONE. AND A MODERATE BLEEDING IN AT LEAST 1-2 PATIENTS REQUIRING REPEAT ENDOSCOPY. AN UNSPECIFIED INJECTION AND A SELF-EXPANDABLE METAL STENTS (SEMS) WERE ALSO USED AS PART OF MEDICAL INTERVENTION. THE BLEEDING WERE STABILIZED FOLLOWING ENDOSCOPIC THERAPY IN ALL PATIENTS EXCEPT IN ONE PATIENT WHO NEEDED IR EMBOLIZATION. FURTHER INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THIS REPORT IS FOR PATIENT #4 OF 5, REQUIRING REPEAT ENDOSCOPY.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23943598 ↗
• InjuryJan 2, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURES, THE SETTINGS OF THIS ELECTROSURGICAL GENERATOR WERE JUMPING ACROSS PROFILES. THE USER FELT AS IF THE "CUT WAS TOO HARSH" AND "THE COAG WAS SHARP". IT WAS NOTED THAT THERE WAS AN INCREASE IN "SPENTROTAMY" BLEEDS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE OCCURRENCES OF BLEEDING WERE DETECTED AFTER THE PROCEDURE. THERE WAS SIGNIFICANT BLEEDING IN AT LEAST TWO PATIENTS NECESSITATING BLOOD TRANSFUSION AND INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION IN ONE. AND A MODERATE BLEEDING IN AT LEAST 1-2 PATIENTS REQUIRING REPEAT ENDOSCOPY. AN UNSPECIFIED INJECTION AND A SELF-EXPANDABLE METAL STENTS (SEMS) WERE ALSO USED AS PART OF MEDICAL INTERVENTION. THE BLEEDING WERE STABILIZED FOLLOWING ENDOSCOPIC THERAPY IN ALL PATIENTS EXCEPT IN ONE PATIENT WHO NEEDED IR EMBOLIZATION. FURTHER INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THIS REPORT IS FOR PATIENT #5 OF 5, REQUIRING REPEAT ENDOSCOPY.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23943593 ↗
• InjuryDec 30, 2025Energy Output Problem; Energy Output Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23930724 ↗
• InjuryDec 30, 2025Energy Output Problem; Energy Output Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23930722 ↗
• InjuryDec 30, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURES, THE SETTINGS OF THIS ELECTROSURGICAL GENERATOR WERE JUMPING ACROSS PROFILES. THE USER FELT AS IF THE "CUT WAS TOO HARSH" AND "THE COAG WAS SHARP". IT WAS NOTED THAT THERE WAS AN INCREASE IN "SPENTROTAMY" BLEEDS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE OCCURENCES OF BLEEDING WERE DETECTED AFTER THE PROCEDURE. THERE WAS SIGNIFICANT BLEEDING IN AT LEAST TWO PATIENTS NECESSITATING BLOOD TRANSFUSION AND INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION IN ONE. AND A MODERATE BLEEDING IN AT LEAST 1-2 PATIENTS REQUIRING REPEAT ENDOSCOPY. AN UNSPECIFIED INJECTION AND A SELF-EXPANDABLE METAL STENTS (SEMS) WERE ALSO USED AS PART OF MEDICAL INTERVENTION. THE BLEEDING WERE STABILIZED FOLLOWING ENDOSCOPIC THERAPY IN ALL PATIENTS EXCEPT IN ONE PATIENT WHO NEEDED IR EMBOLIZATION. FURTHER INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THIS REPORT IS FOR PATIENT #1 OF 5, REQUIRING BLOOD TRANSFUSION.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23930707 ↗
• MalfunctionOct 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349294 ↗
• MalfunctionOct 20, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337039 ↗
• MalfunctionSep 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A LAPARASKOPI PROCEDURE, THE SUBJECT GENERATOR DEVICE GAVE AN ERROR 274. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072788 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLONOSCOPY WITH POLYP REMOVAL, A PERFORATION OCCURRED. THIS OCCURRED DURING THE USE OF THE OLYMPUS GENERATOR AND A NON-OLYMPUS POLYPECTOMY SNARE. THE CUSTOMER BELIEVES THE CAUSE IS NOT RELATED TO THE INTEGRITY OF THE DEVICE, BUT TO BE 100% SURE, THEY ARE SENDING THE DEVICE FOR REPAIR. ADDITIONAL INFORMATION INDICATED THAT THE CUSTOMER STATED THE EVENT WAS CAUSED BY INCORRECT OPERATION BY THE DOCTOR AND NOT A PROBLEM WITH THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR CLARIFICATION; HOWEVER, IT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Bowel Perforation

  MAUDE report 22889481 ↗
• MalfunctionSep 30, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE GENERATOR EXHIBITED ERROR 231 INTERMITTENTLY WHEN UNIT WAS TURNED ON. THE STAFF CONNECTED OR DISCONNECTED THE CABLES, BUT THE ERROR STILL POPPED UP A FEW TIMES. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT IMPACT AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333098 ↗
• MalfunctionAug 6, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE ELECTROSURGICAL SYSTEM GENERATOR HAD AN E215 ERROR CODE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917988 ↗
• MalfunctionJul 16, 2024Output Problem; Output Problem

  IT WAS REPORTED THE ELECTROSURGICAL SYSTEM GENERATOR HAD AN E243 (ELECTROSURGICAL GENERATOR MALFUNCTION) ERROR CODE. THE ISSUE OCCURRED DURING REPROCESSING. THE UNSPECIFIED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750915 ↗
• MalfunctionJun 6, 2024Output Problem; Output Problem

  IT WAS REPORTED, THAT THE ELECTROSURGICAL SYSTEM GENERATOR HAD A PERMANENT REBOOT ERROR: E234. THE ISSUE OCCURRED DURING OTHER EVENTS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475557 ↗
• MalfunctionMay 17, 2024Output Problem; Output Problem

  THE INTENDED PROCEDURE WAS DIAGNOSTIC IN NATURE AND COMPLETED USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342852 ↗
• MalfunctionDec 22, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OLYMPUS ESG-100 DEVICE HAD ERROR E248. THE CUSTOMER OBSERVED THE ISSUE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED AND NO PROCEDURE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383752 ↗
• MalfunctionDec 11, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OLYMPUS ESG-100, 220...240 V HAD AN ERROR MESSAGE SHOWING. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: CLARIFIED THE ERROR AS E317. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304457 ↗
• MalfunctionOct 3, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER RETURNED THE ELECTROSURGICAL GENERATOR FOR EVALUATION OF A REPORTED ¿ERROR 282¿, THAT PERMANENT ALARMS WHEN ATTEMPTING TO USE. THE PROBLEM WAS FOUND DURING PREPARATION FOR USE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865591 ↗
• MalfunctionSep 3, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS ESG-100, DISPLAYED ERROR CODE E234. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNKNOWN DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675021 ↗
• MalfunctionAug 23, 2023Communication or Transmission Problem; Communication or Transmission Problem

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER ERROR CODE E274 (GENERATOR ERROR MESSAGE) WITH USE OF OLYMPUS ESG-100, 220...240 V~,. THE MALFUNCTION WAS FOUND DURING INSPECTION FOR USE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603538 ↗
• MalfunctionJul 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE INTENDED PROCEDURE WAS A GASTROSCOPY EXAMINATION. POLYPS WERE FOUND AND CUT OUT. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318258 ↗
• InjuryJun 14, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE SETTINGS USED WERE PULSECUT 40 WATTS AND SOFTCOAG 30 WATTS. THE PHYSICIAN RECALLED THEY MIGHT HAVE STEPPED ON THE WRONG PADDLE WHEN SNARING AND STEPPED ON SOFTCOAG INSTEAD OF PULSECUT. THERE WAS NO ALLEGATION OF ANY MALFUNCTION AGAINST THE OLYMPUS GENERATOR. THE PATIENT WAS CURRENTLY STABLE AND IN GOOD HEALTH.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 17131893 ↗
• InjuryMay 25, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING COLONOSCOPY WITH POLYPECTOMY PROCEDURE FOR TWO (2) PATIENTS USING THIS GENERATOR, THE SCREEN WENT FLICKERY A COUPLE OF TIMES AND THE NOISE OF CAUTERY SOUNDED WRONG. THE FLICKERING OF THE SCREEN COINCIDE WITH ACTIVATION OF THE DEVICE. THE NURSING STAFF MADE SOME CHECK WITH ALL CONNECTIONS AND FOUND NO PROBLEM. THE PROCEDURE WAS CONTINUED AND APPARENTLY NORMAL. IN THE FIRST PATIENT, SEVEN POLYPS WERE COLD SNARED AND TWO WERE HOT-SNARED AND ALL SEEMED ALRIGHT, THE LARGEST POLYP WAS ON A DISTAL LIP OF ILEOCECAL VALVE ABOUT 20 MM, REMOVED EN-BLOCK AND HAD NO APPARENT CONCERNS. THE SECOND PATIENT HAD EXTENSIVE DIVERTICULOSIS AND A SOLITARY 12MM LP POLYP WITH A GOOD STALK IN DISTAL DESCENDING COLON. THE POLYP WAS SNARED REASONABLY WELL. WHEN TRYING TO RETRIEVE THE POLYP, FOUND A LITTLE CAUTERY BURN, A BLACK DOT, LIKELY SITE OF PERFORATION. THREE METAL CLIPS WERE USED TO CLOSE IT. BOTH PATIENTS DEVELOPED PAIN IN THE RECOVERY ROOM. SETTINGS USED IN PATIENT WITH PEDUNCULATED POLYP WAS FORCE COAG EFFECT 2 AND W 20. IN THE CECAL POLYP NORMAL EMR SETTING SLOW CUT W 120, EFFECT 2 WAS USED. THE PATIENT WITH TWO POLYPS REMOVED WITH HOT SNARE, DISTAL LIP

  Patient problems: Bowel Perforation; Pain

  MAUDE report 17007593 ↗