Olympus WB91051WRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Quick summary
This Olympus electrosurgical unit cuts and seals tissue using electrical energy. Many reports describe electrical faults, communication problems, and output or activation failures, and some mention burns or bleeding. The records include 1,920 reports, 135 injuries and 1 death, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,951
- Deaths reported
- 1
- Injuries reported
- 135
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,951 adverse event reports that list this exact device (DI 04042761076838), received between Aug 6, 2018 and Sep 30, 2026 — classified as 1 death, 135 injuries, 1,815 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (598 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.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem598
- Communication or Transmission Problem595
- Output Problem359
- Activation Problem228
- Adverse Event Without Identified Device or Use Problem60
- Image Display Error/Artifact57
- Unexpected Shutdown50
- Electrical Shorting49
Patient problems
- No Clinical Signs, Symptoms or Conditions1,743
- No Consequences Or Impact To Patient62
- Hemorrhage/Blood Loss/Bleeding27
- Insufficient Information24
- No Patient Involvement24
- Burn(s)19
- No Known Impact Or Consequence To Patient18
- Perforation11
Recent adverse event reports
The 25 most recent of 1,951 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951788 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
The customer reported an error E433 during lab/demonstration involving an Olympus Generator. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943957 ↗MalfunctionSep 29, 2026Communication or Transmission Problem; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934406 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported the Generator had an E433 error during an unspecfied procedure. During the initial evaluation of the device it was observed, the generator board had failed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900083 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported during setup involving an Olympus Generator the staff received a message indicating that the saline being used was incorrect or incompatible. Customer stated the unit was connected to a bipolar cable and probe, and saline was connected as usual. The exact error message was not available. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899463 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported an error E433 displayed during set-up involving an Olympus Generator. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892869 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892533 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
The customer reported error E486 and error E006 displayed during a therapeutic Bipolar Turp procedure involving an Olympus Bronchovideoscope. There was no delay and the procedure was complete using the same device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882507 ↗MalfunctionSep 24, 2026Power Problem
It was reported that the Electrosurgical generator ESG-400 displayed an E433 error, and the system is restarting automatically. The issue occurred during set up or Inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876826 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer reported the Generator had a separate issue. During the initial evaluation of the device it was observed, an E433 error occurred. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871130 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer reported the Electrosurgical generator ESG-400, had a separate issue. During the initial evaluation display of error code e433, was noted. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870425 ↗MalfunctionSep 22, 2026Unintended Power Up; Communication or Transmission Problem
The customer reported after switching on system it automatically restarted with E433 error during set up. There was no patient injury reported. During the initial evaluation it was observed that a defective generator board caused Error E433 and automatic restarted the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854064 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
The customer reported an Error E433 during setup/inspection for use on an Olympus Electrosurgical generator ESG-400. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845704 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
It was reported that during service / maintenance (not in a clinical setting), the generator gave an Error E433 Automatically Restart. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842006 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
It was reported that the Electrosurgical generator ESG-400 diathermy immediately displays error E433 upon startup, and the image would turn on and off. The issue occurred during preparation for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835269 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
The customer reported the Electrosurgical generator ESG-400 had a separate issue. During the initial evaluation of the device it was observed, error code E433- continuous restart was noted. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835240 ↗MalfunctionSep 18, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831089 ↗MalfunctionSep 18, 2026Communication or Transmission Problem
The customer returned the Generator for a separate issue. During the initial evaluation of the returned device, an E433 error was observed.There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822488 ↗MalfunctionSep 18, 2026Communication or Transmission Problem
The customer reported that when using the universal output of the electrosurgical generator, the message "No instrument connected" appeared on the screen during an unspecified procedure and therefore, switched to a different device. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819910 ↗MalfunctionSep 17, 2026Communication or Transmission Problem
It was reported that the Electrosurgical generator ESG-400 exhibited Error 006. The malfunction was identified during a procedure, and it is unknown how the procedure was completed. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804504 ↗MalfunctionSep 15, 2026Communication or Transmission Problem
It was reported the Generator displayed an E433 error message during maintenance. During the initial evaluation of the device it was observed, the high voltage power supply board had failed. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778961 ↗MalfunctionSep 15, 2026Communication or Transmission Problem
The customer reported error code E433 during inspection for use involving an Olympus Generator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778929 ↗MalfunctionSep 14, 2026Communication or Transmission Problem; Activation Failure
The customer returned the Electrosurgical generator ESG-400 to the service center for a separate issue. During the device analysis, the investigator indicated the display of error code E433. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759822 ↗MalfunctionSep 11, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736222 ↗MalfunctionSep 11, 2026Communication or Transmission Problem
The customer reported error code E486 during inspection for use involving an Olympus Generator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733740 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.