Olympus WB50402WRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04042761076807), received between Jan 7, 2022 and Aug 14, 2025 — classified as 2 injuries, 10 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FORM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806192 ↗
• MalfunctionOct 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FOOT SWITCH OF THE ELECTROSURGICAL GENERATOR HAD AN ERROR CODE E433. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453424 ↗
• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORTED THE ELECTRODE TIP BROKE WHILE PEELING OFF THE FIBROID. THE BROKEN PART HAS BEEN COLLECTED. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF FIBROIDS (TCRF) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209856 ↗
• MalfunctionApr 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GENERATOR FOOT SWITCH OF ELECTROSURGICAL GENERATOR HAD AN ERROR CODE OF E433. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152341 ↗
• MalfunctionMar 19, 2024Power Problem; Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE FOOT SWITCH, DOUBLE, FOR, ESG-400 HAD AN E433 ERROR. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928797 ↗
• MalfunctionSep 15, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHEN USING THE FOOT SWITCH, DOUBLE WITH THE HIGH FREQUENCY GENERATOR DURING A PROCEDURE, AN E433 ERROR MESSAGE WAS DISPLAYED. THE CUSTOMER NOTED THE FOOT SWITCH WAS IN BAD CONDITION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755284 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT AN ELECTRICAL FAILURE OCCURRED AND NO IMAGE DURING THE HYSTEROSCOPIC MYOMECTOMY AND THE SAME PROBLEM OCCURRED AFTER REPLACING ALL THE COMBINED DEVICES CAUSING A 30-MINUTE DELAY IN SURGERY AND 30 MINUTES EXTENDED ANESTHESIA TIME. THERE WERE NO ERROR MESSAGES. THE PROCEDURE WAS COMPLETED USING OTHER UROLOGICAL PRODUCTS. THE EVENT DID NOT AFFECT THE DIAGNOSTIC OR TREATMENT OUTCOME. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 12 REPORTS. RELATED PATIENT IDENTIFIERS FOR THE FIRST COMBINATION OF DEVICES USED ARE AS FOLLOWS: (B)(6) (WA00014A / HF-CABLE, BIPOLAR), (B)(6) (WA00014A / HF-CABLE, BIPOLAR), (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS), (B)(6)(A42021A / OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE), (B)(6) (WA22366A /WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6)(WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400). RELATED PATIENT IDENTIFIERS FOR THE SECOND COMBINATION OF DEVICES USED: (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400), (B)(6) (WA22366A / WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374812 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT AN ELECTRICAL FAILURE OCCURRED AND NO IMAGE DURING THE HYSTEROSCOPIC MYOMECTOMY AND THE SAME PROBLEM OCCURRED AFTER REPLACING ALL THE COMBINED DEVICES CAUSING A 30-MINUTE DELAY IN SURGERY AND 30 MINUTES EXTENDED ANESTHESIA TIME. THERE WERE NO ERROR MESSAGES. THE PROCEDURE WAS COMPLETED USING OTHER UROLOGICAL PRODUCTS. THE EVENT DID NOT AFFECT THE DIAGNOSTIC OR TREATMENT OUTCOME. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 12 REPORTS. RELATED PATIENT IDENTIFIERS FOR THE FIRST COMBINATION OF DEVICES USED ARE AS FOLLOWS: (B)(6) (WA00014A / HF-CABLE, BIPOLAR), (B)(6) (WA00014A / HF-CABLE, BIPOLAR), (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS), (B)(6) (A42021A / OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE), (B)(6) (WA22366A /WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400). RELATED PATIENT IDENTIFIERS FOR THE SECOND COMBINATION OF DEVICES USED: (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400), (B)(6) (WA22366A / WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374619 ↗
• MalfunctionJun 2, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OLYMPUS WAS INFORMED AFTER AN UPGRADE DURING AN ANNUAL MAINTENANCE, THE CUSTOMER HIGH FREQUENCY ELECTRO-SURGICAL GENERATOR WAS HAVING PROBLEMS WITH SEVERAL ERRORS. DURING THE DEVICE INVESTIGATION OLYMPUS, FOUND IT CANNOT BE RULED OUT THAT ERROR MESSAGE E433 WAS CAUSED BY A DEFECTIVE DOUBLE FOOT SWITCH. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION OF THE FOOT SWITCH FOUND DURING EVALUATION. THIS MDR IS RELATED TO PATIENT IDENTIFIER: (B)(6) (GENERATOR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046651 ↗
• MalfunctionMay 16, 2023Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO OLYMPUS, THAT AN HF UNIT (GENERATOR) HAD AN E433 FOOTSWITCH ERROR. IT IS UNKNOWN, WHEN THE REPORTED ISSUE WAS FOUND. THE CUSTOMER SOLVED THE REPORTED ISSUE DURING TROUBLESHOOTING. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942845 ↗
• MalfunctionJul 18, 2022Activation Problem; Activation Problem

  OLYMPUS WAS INFORMED THAT AFTER THE INSPECTION OF THE ELECTROSURGICAL GENERATOR ¿ESG-400¿ WHICH WAS FOUND TO MEET ITS SPECIFICATION, THE AFFECTED FOOT SWITCH WAS CONNECTED TO THE GENERATOR RESULTING IN DISPLAYING ERROR MESSAGE E433. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040576 ↗
• MalfunctionJan 7, 2022Break; Break

  THE SERVICE CENTER WAS INFORMED BY THE BIOMEDICAL ENGINEER AT THE USER FACILITY THAT THE FOOT SWITCH, DOUBLE FOR THE ESG-400 REPORTEDLY HAD AN "THE WIRES ARE EXPOSED ON THE FOOTPEDAL" DURING RECEIPT INSPECTION. NO PATIENT INJURY OR HARM WAS REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13194612 ↗