Olympus WA00013ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042761030489), received between Jun 3, 2021 and Nov 26, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23660857 ↗
• MalfunctionOct 13, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-CABLE HAD INSTRUCTIONS FOR USE THAT WERE POSSIBLY INCORRECT. THE EVENT WAS NOTICED PRIOR TO A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930271 ↗
• MalfunctionSep 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-CABLE HAD AN ER08 AND AN OPEN CIRCUIT. THE EVENT OCCURRED DURING A PROCEDURE. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THERE WAS A DAMAGED CABLE. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798781 ↗
• MalfunctionNov 15, 2022Sparking; Sparking

  THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR A THERAPEUTIC PROCEDURE, SPARKS WERE PRESENT WHEN THE HF-CABLE WAS CONNECTED TO THE UES-40. UPON RECONNECTING, THE DEVICE DID NOT POWER ON. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802271 ↗
• MalfunctionNov 26, 2021Break; Arcing; Sparking; Break; Arcing; Sparking

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE, THE HF-CABLE BROKE AND SPARKED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR CABLE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877772 ↗
• InjuryJun 3, 2021Output Problem; Activation Problem; Output Problem; Activation Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE, ERROR MESSAGE E02 OCCURRED FREQUENTLY AND THE PROCEDURE COULD NOT BE COMPLETED BUT HAD TO BE POSTPONED. THE INTENDED PROCEDURE WAS THEN COMPLETED ON ANOTHER DAY WITH A DIFFERENT HF CABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929036 ↗