Olympus WA90300WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761085977), received between Feb 10, 2023 and Dec 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886504 ↗
• InjuryDec 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED WHEN THE ARGON PLASMA COAGULATION UNIT WAS CONNECTED TO THE ELECTROSURGICAL GENERATOR, AN E679 ERROR CODE WAS DISPLAYED AND THE "GREEN TANK" ICON EXPECTED TO BE ON THE DISPLAY WAS NOT PRESENT. THE ISSUE OCCURRED DURING A THERAPEUTIC COLONOSCOPY AND THE PROCEDURE WAS PROLONGED GREATER THAN 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885765 ↗
• InjuryNov 26, 2024Unintended Electrical Shock; Unintended Electrical Shock

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Abdominal Pain; Necrosis; Perforation

  MAUDE report 20789656 ↗
• InjuryFeb 10, 2023Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM AN OLYMPUS REPRESENTATIVE ON BEHALF OF THE CUSTOMER. THE DEVICE REPORTEDLY EXHIBITED "TOO MUCH" CAUTERIZATION, WHICH CAUSED "TOO MUCH" TISSUE WHITENING WITHOUT ANY BLEEDING AT THAT TIME. THE INJURY WAS DESCRIBED AS MILD.

  Patient problems: Burn(s)

  MAUDE report 16354581 ↗
• InjuryFeb 10, 2023Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM AN OLYMPUS REPRESENTATIVE ON BEHALF OF THE CUSTOMER. THE DEVICE REPORTEDLY EXHIBITED "TOO MUCH" CAUTERIZATION, WHICH CAUSED "TOO MUCH" TISSUE WHITENING WITHOUT ANY BLEEDING AT THAT TIME. THE INJURY WAS DESCRIBED AS MILD.

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16354518 ↗