Olympus WB50403WRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761076814), received between Sep 6, 2023 and Jul 23, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem3
- Communication or Transmission Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT SUBJECT DEVICE HAS AN E433 ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 22584004 ↗MalfunctionJan 16, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE GENERATOR DISPLAYED ERROR CODE E433 AND AUTOMATICALLY RESTARTS. THE HIGH VOLTAGE POWER BOARD WAS FOUND TO BE DAMAGED. THE ISSUE WAS FOUND DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18517745 ↗MalfunctionDec 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE ESG-400 DISPLAYED ERROR CODE E433 (INTERNAL SOFTWARE OR HARDWARE ERROR) AND AUTOMATICALLY RESTARTED. THE FOOT SWITCH, SINGLE, FOR, ESG-400 WAS DISCONNECTED, AND THE ERROR CODE WAS CLEARED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18257730 ↗MalfunctionDec 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE ESG-400 DISPLAYED ERROR CODE E433 (INTERNAL SOFTWARE OR HARDWARE ERROR) AND AUTOMATICALLY RESTARTED. THE FOOT SWITCH, SINGLE, FOR, ESG-400 WAS DISCONNECTED, AND THE ERROR CODE WAS CLEARED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18257374 ↗MalfunctionSep 6, 2023Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THAT THE HIGH FREQUENCY ELECTROSURGICAL GENERATOR UNIT HAD AN ERROR CODE E433 DISPLAYED. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. FOR THE ESG-400 DEVICE, PLEASE SEE PATIENT IDENTIFIER (B)(6). THIS FILE CAPTURES THE FOOTSWITCH USED IN CONJUNCTION WITH THE ESG-400.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695682 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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