Olympus WA22766SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14042761085516), received between Aug 5, 2020 and Jun 3, 2026 — classified as 2 deaths, 4 malfunctions.

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

• MalfunctionJun 3, 2026Excessive Heating

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED ELECTRODE SEVERELY BENT PROXIMAL END AND THE DISTAL END LOOP WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25375545 ↗
• MalfunctionMay 28, 2026Material Twisted/Bent

  THE CUSTOMER RETURNED THE HF-RESECTION ELECTRODE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT THE ELECTRODE WAS BENT NEAR THE MIDDLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318144 ↗
• MalfunctionOct 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FREQUENCY RESECTION ELECTRODE "PLASMA-OVALBUTTON" WAS INSPECTED BEFORE USE AND HAD AN ERROR DISPLAYED ON THE SCREEN SAYING ELECTRODE IS HOT. THEY ALSO NOTICED THE YELLOW AND BLUE CLADDING WAS COMING OFF ABOUT THE BUTTON PORTION OF THE ELECTRODE. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE THERAPEUTIC PROCEDURE (PROSTATE VAPORIZATION) WAS COMPLETED WITH A SIMILAR DEVICE. THE ISSUE CAUSED A 10-MINUTE PROCEDURAL DELAY AND EXTENSION OF ANESTHESIA TIME WHILE THE DEVICE WAS REPLACED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920126 ↗
• MalfunctionFeb 27, 2023Defective Component; Defective Component

  OLYMPUS RECEIVED A MEDWATCH REPORT: (B)(4) VIA MAIL WHICH STATES, ¿PER TEAM, THE LOOP ON THE DEVICE WAS DEFECTIVE- A NEW DEVICE NEEDED TO BE OBTAINED FOR THE PROCEDURE.¿ THE CUSTOMER REPORTED DAMAGED LOOP WIRE AT THE DISTAL END OF THE PLASMA-OVAL BUTTON, HIGH FREQUENCY RESECTION ELECTRODE, WAS FOUND AT PROCEDURE. NO OTHER INFORMATION WAS PROVIDED OR OBTAINABLE. NO DEATH, INJURY OR IMPACT TO THE PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448697 ↗
• DeathAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON FURTHER COMMUNICATION WITH THE ATTENDING PHYSICIAN, THE PATIENT'S OUTCOME HAD NOTHING TO DO WITH THE SUBJECT DEVICE. THE PATIENT REPORTEDLY EXPIRED AFTER THE PROCEDURE AND IT WAS REPORTED THAT THE PATIENT'S HEART SUDDENLY STOPPED BUT NO AUTOPSY WAS PERFORMED. THE EXACT CAUSE OF DEATH REMAINS UNKNOWN BUT THE AGE OF THE PATIENT CANNOT BE RULED OUT A CONTRIBUTORY FACTOR.

  Patient problems: Death

  MAUDE report 10374889 ↗
• DeathAug 5, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE OLYMPUS SALES REPRESENTATIVE PRESENT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), THE PATIENT DIED ON THE OPERATING TABLE. IT WAS NOTED THE PATIENT EXPERIENCED HEART RATE COMPLICATIONS APPROXIMATELY THREE FOURTHS OF THE WAY THROUGH THE PROCEDURE. NO ALLEGATION OF DEVICE MALFUNCTION HAS BEEN REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. BRAND NAME: HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", BUTTON, OVAL, 24 FR., 12°-30°, ESG TURIS.

  Patient problems: Death

  MAUDE report 10368833 ↗