Olympus WA91307WRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04042761086332), received between Oct 26, 2021 and Mar 4, 2026 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (7 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24512763 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER USE OF A RESECTOSCOPE WITH ELECTROSURGICAL GENERATOR FOR TRANSURETHRAL RESECTION (TUR) OF THE PROSTATE OR BLADDER, THERE WAS A SIGNIFICANT INCREASE IN POST-OPERATIVE BLEEDING REQUIRING SURGICAL REVISION. IT WAS ADDITIONALLY REPORTED THAT BLEEDING USUALLY OCCURRED IN THE FIRST 2-3 DAYS. THE CONSEQUENCE WAS USUALLY A TUR HEMOSTASIS WITH RENEWED COAGULATION OF THE RESECTION AREAS. THE CUSTOMER REPORTED THAT THE SETTINGS WERE ALWAYS THE SAME: SALINE 1 AS THE RECOMMENDED DEFAULT SETTING AND COAGULATION AT 120, EFFECT 2 AND THERE WAS NEVER AN OFFICIAL ERROR MESSAGE FROM THE DEVICE. ATTEMPTS TO GAIN AMOUNT AND SEVERITY OF BLEEDING WERE UNSUCCESSFUL. REPORT 1 OF 10.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24512651 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506625 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506592 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506528 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506510 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506412 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506394 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506379 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506351 ↗
• MalfunctionAug 28, 2025Electrical /Electronic Property Problem; Self-Activation or Keying; Communication or Transmission Problem; Connection Problem; Electrical /Electronic Property Problem; Self-Activation or Keying; Communication or Transmission Problem; Connection Problem

  THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914773 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A SMALL INTESTINE INJURY 2 WEEKS AFTER TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) SURGERY WAS PERFORMED. SECOND EMERGENCY OPERATION WAS PERFORMED TO FIX THE SMALL INTESTINE INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Bowel Perforation

  MAUDE report 22535130 ↗
• InjuryJun 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE ELECTROSURGICAL GENERATOR HAD UNTIMELY IGNITIONS THAT OCCURRED DURING SEDATION FOR A THERAPEUTIC BLADDER RESECTION, LEADING TO THE PROCEDURE BEING CANCELLED AND NEEDING TO BE RESCHEDULED. IN ADDITION, THIS INCREASED THE LENGTH OF THE HOSPITAL STAY, AND THE PATIENT WAS CURRENTLY AWAITING CONDITIONS FOR RESCHEDULING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330628 ↗
• MalfunctionFeb 24, 2025Output Problem; Output Problem

  DURING THE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED ERROR CODE E006, A WARNING THAT THE USER ACTIVATED THE BIPOLAR MODE IN A NON-CONDUCTIVE LIQUID. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21452522 ↗
• InjuryApr 22, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE POWER OUTPUT WAS NOT CORRECT AND THE PATIENT'S BLADDER WAS INJURED. DURING THE CUTTING PROCESS IN TUR BIPOLAR MODE THE POWER OUTPUT WAS INTERRUPTED. WHEN THEY RESTARTED THE BLADDER WAS PERFORATED (OCCURRED 3 TIMES) AND NEW ELECTRODES WERE USED.

  Patient problems: Internal Organ Perforation

  MAUDE report 19155640 ↗
• MalfunctionMar 12, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED, THE ELECTROSURGICAL GENERATOR "ESG-410" EXHIBITED A BURN MARK ON PATIENT. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE AND THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886297 ↗
• MalfunctionAug 24, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE HANDPIECE FOR CUTTING, AND COAGULATION ON HIS OLYMPUS ELECTROSURGICAL GENERATOR WAS NOT FUNCTIONING ON THE SECOND MONOPOLAR PORT. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611523 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, DAMAGE TO THE DISTAL URETER WAS SUSPECTED BUT COULD NOT BE CONFIRMED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS KEPT IN THE HOSPITAL ONE DAY LONGER THAN USUAL. ON (B)(6) 2022, THE PATIENT RETURNED FOR A FOLLOW-UP EXAMINATION DESCRIBING MILD PAIN IN THE LOWER LEFT ABDOMEN. THE EXAMINATION DID NOT REVEAL ANY INJURIES/COMPLICATIONS BUT SHOWED THAT THE TURBT PROCEDURE HAD BEEN SUCCESSFUL AND THE PATIENT IS DOING WELL. A SECOND FOLLOW-UP EXAMINATION IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Abdominal Pain

  MAUDE report 16094649 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE THAT WAS PERFORMED UNDER SPINAL ANESTHESIA, THE SURGEON HEARD AN EXPLOSION SOUND IN THE BLADDER AND THE PATIENT REPORTED TO FEEL PAIN. THE SURGEON THEN DETECTED A LESION IN THE BLADDER WALL. THE INTENDED PROCEDURE WAS NOT COMPLETED BUT INTERRUPTED AND A BLADDER CATHETER WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 13287979 ↗
• InjuryNov 17, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE AT AN UNKNOWN DATE, THE SURGEON FELT THAT THE ESG-410 HF GENERATOR SHOWED A REDUCED COAGULATION CAPACITY AFTER HAEMOSTATIC ACTION. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT BUT THE PATIENT HAD TO STAY IN HOSPITAL FOR TWO DAYS LONGER THAN PLANNED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12826327 ↗
• InjuryNov 17, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE AT AN UNKNOWN DATE, THE SURGEON FELT THAT THE ESG-410 HF GENERATOR SHOWED A REDUCED COAGULATION CAPACITY AFTER HAEMOSTATIC ACTION. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT BUT THE PATIENT HAD TO STAY IN HOSPITAL FOR TWO DAYS LONGER THAN PLANNED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12826169 ↗
• InjuryNov 17, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE AT AN UNKNOWN DATE, THE SURGEON FELT THAT THE ESG-410 HF GENERATOR SHOWED A REDUCED COAGULATION CAPACITY AFTER HAEMOSTATITC ACTION. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT BUT THE PATIENT HAD TO STAY IN HOSPITAL FOR TWO DAYS LONGER THAN PLANNED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12826076 ↗
• InjuryNov 17, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE SURGEON FELT THAT THE ESG-410 HF GENERATOR SHOWED A REDUCED COAGULATION CAPACITY AFTER HAEMOSTATITC ACTION. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT BUT THE PATIENT HAD TO STAY IN HOSPITAL FOR SEVEN DAYS LONGER THAN PLANNED AND FOUR BLOOD TRANSFUSION BAGS HAD TO BE ADMINISTERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12826057 ↗
• InjuryNov 17, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, THE SURGEON FELT THAT THE ESG-410 HF GENERATOR SHOWED A REDUCED COAGULATION CAPACITY AFTER HAEMOSTATIC ACTION. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT BUT THE PATIENT HAD TO STAY IN HOSPITAL FOR FIVE DAYS LONGER THAN PLANNED AND THREE BLOOD TRANSFUSION BAGS HAD TO BE ADMINISTERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12826046 ↗
• InjuryOct 26, 2021Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING AND AFTER SEVERAL THERAPEUTIC PROSTATE RESECTION PROCEDURES PERFORMED AT THE SAME HOSPITAL OVER A PERIOD OF APPROX. 6 WEEKS IN (B)(6) 2021, THE OPERATING SURGEONS REPORTEDLY NOTED SEVERAL ISSUES/DEFIENCIES WITH THEIR NEW ESG-410 HF-GENERATOR UNIT IN COMPARISON WITH THEIR PREVIOUS HF GENERATOR SETUP. THEY FELT A REDUCED COAGULATION CAPACITY WITH VESSELS REOPENING AFTER THE HAEMOSTATIC ACTION BOTH DURING CUTTING AND COAGULATION. FURTHERMORE, THE SURGEONS REPORTED THAT THEY FELT IT TOOK LONGER TO CLOT/COAGULATE PROSTATE ADENOMA, THAT THERE WAS A GREATER PROSTATIC IRRITATION, LONGER HOSPITAL STAYS (PROLONGED CATHETERIZATIONS DUE TO LOW TISSUE HAEMOSTASIS), AND IN SOME CASES THE NECESSITY OF BLOOD TRANSFUSIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12696031 ↗