Olympus WA22067ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761051620), received between Jun 14, 2019 and May 10, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TRANSURETHRAL RESECTION OF THE BLADDER, THE PATIENT RETURNED TO THE HOSPITAL WITH A URETER BURN. NO FURTHER PATIENT INFORMATION WAS PROVIDED. NO MALFUNCTION OF THE DEVICE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 21999319 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: THE CUSTOMER CLARIFIED 02JUL2021 THAT THE CUSTOMER DOES NOT USE AN OLYMPUS GENERATOR OR OLYMPUS GROUNDING PADS. THE BURN EXPERIENCED BY THE PATIENT IS NOT RELATED TO THE USE OF AN OLYMPUS DEVICE.

  Patient problems: Burn(s)

  MAUDE report 12063878 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT AT THE BEGINNING OF A THERAPEUTIC ANTERIOR GLAND RESECTION OF THE URETHRA PROCEDURE, IT WAS NOTICED THAT AN INCORRECT DEVICE HAD BEEN ORDERED AS A LOANER DEVICE DUE TO WHICH THE SCHEDULED PROCEDURE HAD TO BE SWITCHED FROM A BIPOLAR RESECTION PROCEDURE (TURIS) TO A MONOPOLAR RESECTION PROCEDURE (TURP). THIS RESULTED IN THE PROCEDURE BEING EXTENDED BY 150 TO 180 MINUTES. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT ANY PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 11045863 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROSTATE RESECTION PROCEDURE AN EXPLOSION OCCURRED INSIDE THE PATIENT¿S BLADDER CAUSING A RUPTURE OF THE INTERNAL MUSCULARIS OF THE PATIENT¿S BLADDER. THE INTENDED PROCEDURE WAS CANCELED AND OPEN SURGERY WAS STARTED. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED.

  Patient problems: Rupture

  MAUDE report 9104087 ↗
• MalfunctionJun 14, 2019Use of Device Problem; Use of Device Problem

  THE MANUFACTURER WAS INFORMED THAT DURING THE MIDDLE OF A MONOPOLAR TRANSURETHRAL RESECTION OF A PROSTATE (TURP) PROCEDURE, THE ELECTRODE WAS NOT SEATING CORRECTLY IN THE WORKING ELEMENT WHICH CAUSED CHARRING AT THE POINT WHERE THE ELECTRODE CONTACT THE WORKING ELEMENT. THE ELECTRODE CAN BE DISCONNECTED FROM THE WORKING ELEMENT WITHOUT UNLOCKING IT. AFTER SWITCHING TO A DIFFERENT ELECTRODE AND EXPERIENCING THE SAME PROBLEM. THE PHYSICIAN SWITCHED TO BIPOLAR RESECTION EQUIPMENT AND SUCCESSFULLY FINISHED THE PROCEDURE. THERE WAS MODERATE BLEEDING WHICH WAS ATTEMPTED TO BE CONTROLLED BY USING MONOPOLAR COAG, BUT EVENTUALLY SWITCHING TO BIPOLAR. THE PROCEDURE WAS DELAYED BY TEN TO FIFTEEN MINUTES. THERE WAS NO ERROR MESSAGES OBSERVED FROM THE GENERATOR. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701850 ↗