Olympus WB991046Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 04042768910463), received between Jun 28, 2018 and Sep 21, 2026 — classified as 35 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (15 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847859 ↗
• MalfunctionFeb 6, 2026Electrical /Electronic Property Problem; Power Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS ESG-100 ENCOUNTERED AN E0246 ERROR DUE TO A COMPONENT FAILURE OF THE INTERNAL ELECTRONIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280804 ↗
• MalfunctionFeb 5, 2026Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269554 ↗
• MalfunctionDec 26, 2025Electrical /Electronic Property Problem; Communication or Transmission Problem; Electrical /Electronic Property Problem; Communication or Transmission Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT GENERATOR HAD AN E216 AND E234 ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895615 ↗
• MalfunctionDec 8, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE GENERATOR GOES TO THE STANDBY IMAGE, THE FOOTSWITCH DOES NOT RESPOND, SHOWS AN ERROR CODE 234 AND THE POWER DOES NOT TURN ON THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752368 ↗
• MalfunctionDec 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE GENERATOR HAD AN E215 ERROR. THE ISSUE WAS OBSERVED DURING PRE-USE INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711294 ↗
• MalfunctionOct 15, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED WHEN THE FACILITY TURNED ON THE GENERATOR, ERROR E248 OCCURRED. IT BECAME UNUSABLE AND THE PLANNED THERAPEUTIC PROCEDURE WAS CANCELLED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303292 ↗
• MalfunctionAug 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE GENERATOR HAD AN E234 ERROR. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC ENDOSCOPY/POLYPECTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883496 ↗
• MalfunctionAug 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE GENERATOR HAD AN E215 ERROR. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883481 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A THERAPEUTIC COLONOSCOPY, THE PHYSICIAN WAS PERFORMING A SIGMOID POLYPECTOMY WHEN THE YELLOW FOOT PEDAL OF THE ESG-100 WAS INADVERTENTLY PRESSED. THE PHYSICIAN REPORTED THAT THIS ACTION CAUSED THE GENERATOR TO SWITCH FROM COAG TO CUT MODE, RESULTING IN AN UNINTENDED CUT AND A PERFORATION OF THE SIGMOID COLON AT APPROXIMATELY 20 CM. THE PERFORATION WAS IDENTIFIED VISUALLY DURING THE PROCEDURE. THE SIZE AND DEPTH OF THE INJURY WERE NOT RECORDED. SIX HEMOSTASIS CLIPS WERE PLACED TO STABILIZE THE PERFORATION SITE, AND THE PATIENT WAS TRANSFERRED TO A HOSPITAL FOR FURTHER TREATMENT. THE PATIENT UNDERWENT A SIGMOID COLON RESECTION WITH OSTOMY. NO ICU ADMISSION WAS REQUIRED, AND NO POST-OPERATIVE COMPLICATIONS SUCH AS PERITONITIS OR SEPSIS WERE REPORTED. THE PATIENT WAS DISCHARGED HOME. AN OSTOMY REVERSAL PROCEDURE IS SCHEDULED FOR A LATER DATE. THERE IS NO ALLEGED OR CONFIRMED DEVICE MALFUNCTION.

  Patient problems: Bowel Perforation

  MAUDE report 22742225 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Bowel Perforation

  MAUDE report 22742209 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC POLYPECTOMY PROCEDURE UNDER SEDATION, THE GENERATOR WAS SET AT A LOWER VALUE THAN RECOMMENDED, THE CUT WAS EXTREME AND THE TISSUE COULD NOT COAGULATE THAT CAUSED AN UNSPECIFIED AMOUNT OF BLEEDING. HEMOSTASIS WAS ACHIEVED BY CLIPPING. THE GENERATOR WAS REPLACED WITH ANOTHER PRODUCT FROM THE SAME MANUFACTURER AND THE PROCEDURE WAS COMPLETED. NO REPORT OF HEALTH HAZARDS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22292214 ↗
• InjuryJun 16, 2025Energy Output Problem; Energy Output Problem

  DURING A THERAPEUTIC POLYPECTOMY PROCEDURE USING THE GENERATOR, THERE WAS INITIALLY NO OUTPUT OBSERVED, FOLLOWED BY A SUDDEN RETURN OF OUTPUT ACCOMPANIED BY AN INCREASE IN BLEEDING THAT WAS GREATER THAN EXPECTED. HEMOSTASIS WAS ACHIEVED THROUGH THE APPLICATION OF A CLIP. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22212192 ↗
• MalfunctionJun 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE GENERATOR DISPLAYED RANDOM 231 ERRORS. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204763 ↗
• MalfunctionJun 11, 2025Output Problem; Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184222 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22019340 ↗
• MalfunctionMar 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682876 ↗
• MalfunctionDec 13, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE GENERATOR PRODUCED THE ERROR CODE NUMBER 248, IT THEN BECAME UNUSABLE, AND THE PLANNED PROCEDURE WAS CANCELLED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931079 ↗
• MalfunctionDec 6, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE, THE ESG-100 GENERATOR MODE CHANGES WHILE IN USE, "WHILE USING PULSE CUT SLOW, IT SUDDENLY CHANGED TO SOFT COAGULATION." THERE PROCEDURE WAS PROLONGED LESS THAN 30 MINUTES AND WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER. THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870015 ↗
• MalfunctionOct 21, 2024Power Problem; Power Problem

  IT WAS REPORTED, THE OLYMPUS ESG-100, 100...120 V~, DISPLAYED ERROR CODE E234. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494186 ↗
• MalfunctionSep 27, 2024Output Problem; Output Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ELECTROSURGICAL SYSTEM GENERATOR EXHIBITED AN E246 ERROR DUE TO A CONTROL BOARD FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318512 ↗
• MalfunctionSep 24, 2024Output Problem; Output Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ELECTROSURGICAL SYSTEM GENERATOR EXHIBITED AN ERROR CODE AND NEW PHENOMENON. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296818 ↗
• MalfunctionSep 16, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED AN E242 ERROR CODE SHORTLY AFTER TURNING ON THE POWER. AFTER TURNING THE POWER OFF AND ON, THE PROCEDURE WAS STILL ABLE TO BE PERFORMED. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232689 ↗
• MalfunctionSep 5, 2024Output Problem; Output Problem

  IT WAS REPORTED, THE ELECTROSURGICAL SYSTEM GENERATOR HAD AN E231 (ELECTROSURGICAL GENERATOR MALFUNCTION) ERROR CODE. THE ISSUE OCCURRED, DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147324 ↗
• MalfunctionAug 8, 2024Output Problem; Output Problem

  IT WAS REPORTED THE ELECTROSURGICAL GENERATOR HAD AN E246 SOCKET SENSOR FAILURE ERROR. THE ISSUE OCCURRED DURING A MAINTENANCE EVENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944961 ↗