Skip to content

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

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Electrosurgical, Cutting & Coagulation & Accessories devices

All Electrosurgical, Cutting & Coagulation & Accessories devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page