Olympus WA22507DRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 14042761068236), received between Mar 11, 2019 and Feb 11, 2026 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 8, 2023Open, Classified

   Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

   Z-2413-2023 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317713 ↗
• MalfunctionDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THE HF-RESECTION ELECTRODE'S RESECTION LOOP FRACTURED. THE MALFUNCTION OCCURRED DURING A RESECTION OF A UTERINE POLYP PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687096 ↗
• MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439462 ↗
• MalfunctionOct 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE SUBJECT DEVICE SLING WAS CLEARLY DEFORMED WHEN IT WAS TAKEN OUT OF THE PACKAGE. THE ISSUE OCCURRED DURING SEDATION WHILE THE DEVICE WAS OUTSIDE OF THE PATIENT FOR A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426831 ↗
• InjuryOct 29, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL NUMBER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23410987 ↗
• MalfunctionSep 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE HAD A LOOP THAT BENT EASILY AND COULD NOT SCRAPE TISSUE. THE EVENT OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043394 ↗
• MalfunctionJul 15, 2025Circuit Failure; Energy Output Problem; Circuit Failure; Energy Output Problem

  IT WAS REPORTED THE SUBJECT DEVICE HAD AN ELECTRICAL LEAK FROM AN UNINTENDED LOCATION AND PART OF THE URETHRA WAS BURNED. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506680 ↗
• MalfunctionJul 3, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394816 ↗
• MalfunctionFeb 21, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: PROCEDURE PERFORMED WAS A THERAPEUTIC PROCEDURE, A TURP/BT- TRANS URETHRAL RESECTION OF BLADDER TUMOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439929 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ELECTRODE INSULATING SHEATH CAME LOOSE. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509910 ↗
• MalfunctionJun 3, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THE RESECTION ELECTRODE LOOP DURING A BIPOLAR TRANSURETHRAL WAS LACKING IN ENERGY AND REQUIRE SOME TIME FOR THE ENERGY TO REACH THE RESECTION LOOP. THE RESECTION LOOP ALSO KEPT PUSHING BACKWARDS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454095 ↗
• MalfunctionFeb 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES INTO THE TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE HIGH FREQUENCY-RESECTION ELECTRODE LOOP WIRE WAS DETACHED FROM ONE OF THE BIPOLAR CONNECTION SITES. THE LOOP WAS CAREFULLY AND FULLY REMOVED FROM THE PATIENT. THERE WERE NO FOREIGN PIECES OBSERVED IN PATIENT AND NO NOTED INJURY TO THE PATIENT. A NEW LOOP WAS OPENED AND RE-ASSEMBLED. PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682883 ↗
• InjuryDec 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT TWO HF-RESECTION ELECTRODE LOOPS BROKE INSIDE THE PATIENT DURING A THERAPEUTIC SURGICAL HYSTEROSCOPY. THE ISSUE OCCURRED IN THE MIDDLE OF THE PROCEDURE WHEN CUTTING A FIBROID VERY HARD. A FRAGMENT OF THIS RESECTION LOOP FELL INSIDE THE PATIENT, AND THE DOCTOR CONSIDERED THAT THE FRAGMENT CAME OUT WHEN PIECES OF THE REMAINING FIBROID WERE REMOVED. THE PROCEDURE WAS DELAYED BY ABOUT 20 MINUTES WITH THE PATIENT UNDER EPIDURAL ANESTHESIA AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE MEDWATCH UNDER RELATED PATIENT IDENTIFIER (B)(6) REPORTS THE OTHER RESECTION LOOP THAT BROKE BUT DID NOT FALL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378184 ↗
• MalfunctionDec 19, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30° HAD THE TWO RESECTION LOOPS BREAK INSIDE THE PATIENT. THE ISSUE WAS FOUND DURING THE THERAPEUTIC SURGICAL HYSTEROSCOPY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE AND A 20 MINUTE DELAY. THERE WERE NO REPORTS OF PATIENT HARM AS THE DEVICE BROKE INSIDE ITSELF AND DID NOT FALL INTO THE PATIENT. RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361054 ↗
• MalfunctionOct 26, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE, INTERMITTENT INSUFFICIENT CONDUCTIVITY ERROR CODE, E006, OCCURRED CAUSING THE PROCEDURE TO HALT INTERMITTENTLY. THE PROCEDURE WAS COMPLETED WITH THE HOSPITAL¿S OWN MONOPOLAR SYSTEM. THE DEVICE WAS RETURNED FOR EVALUATION AND THE EVALUATION IDENTIFIED THE FOLLOWING REPORTABLE MALFUNCTION: THE LOOP AND FORKS AT THE DISTAL END OF THE ELECTRODE WERE DEFORMED. NO INJURY TO THE PATIENT HAS BEEN REPORTED. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016743 ↗
• MalfunctionSep 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE, 12 PCS., FOR TURIS TWO THIN CUTTING LOOP BROKE WHEN IT CAME INTO CONTACT WITH THE UROCLIPS. ONE LOOP WAS LOCATED AND RETRACTED. THE BLADDER WAS FLUSHED, AND MEDICAL PROFESSIONALS LOOKED FOR THE OTHER LOOP HOWEVER, THE SECOND LOOP COULD NOT BE LOCATED OR RETRIEVED. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821118 ↗
• MalfunctionSep 25, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FREQUENCY RESECTION ELECTRODE BROKE DURING THE PROCEDURE. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE INTENDED PROCEDURE WAS TRANSURETHRAL RESECTION OF THE PROSTATE IN SALINE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814494 ↗
• MalfunctionSep 12, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PREPARATION FOR USE THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE, 12 PCS., FOR TURIS HANDLE TWISTED AS SOON AS THE PACKAGE WAS OPENED. 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 WERE ORGANIC RESIDUES ON THE LOOP. 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 17730342 ↗
• InjuryAug 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE HIGH FREQUENCY RESECTION ELECTRODE BROKE AT THE END OF A THERAPEUTIC HYSTEROSCOPY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE, BUT THE BROKEN PIECE OF THE DEVICE WAS NOT RETRIEVED AND REMAINED WITHIN THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTION WAS TAKEN, AND THERE IS NO PLAN TO RETRIEVE THE FRAGMENT AS THE LOCATION WAS UNDETERMINED AND THE DEVICE ENDS SEEMED TO BE BURNED. THE HOSPITAL STAY OF THE PATIENT WAS NOT EXTENDED DUE TO THE DEVICE MALFUNCTION, AND THERE WERE NO ADDITIONAL REPORTS OF PATIENT HARM OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17484623 ↗
• MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS AFTER REMOVING THE WORKING DEVICE FROM THE PATIENT¿S CAVITY, THE SURGEON NOTICED THE ELECTRODE HAD BROKE WITHOUT DOING ANYTHING BEYOND THE SURGICAL ROUTINE. THE MALFUNCTION WAS FOUND DURING THE THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT, USER HARM OR PROCEDURE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405673 ↗
• MalfunctionJun 12, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THE PROCEDURE THAT THE FORK TUBES AT THE DISTAL END OF THE ELECTRODE WERE BENT AND TWISTED WHEN IT ENTERED THE CAVITY. THE PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113578 ↗
• MalfunctionJun 6, 2023Break; Break

  THE CUSTOMER REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HIGH FREQUENCY ELECTRODE ¿RUPTURED ON THE SECOND APPROACH¿. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES. THE CUSTOMER REPORTED THE OUTPUT SETTINGS FROM THE GENERATOR MACHINE WERE UNKNOWN. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074145 ↗
• InjuryJun 2, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT DURING AN ENDOMETRIAL HYSTERECTOMY, THE SURGEON FOUND THE LOOP WIRE OF THE HIGH FREQUENCY RESECTION ELECTRODE WAS CUT IN TWO. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. ALTHOUGH THERE WAS A DELAY OF INTERVENTION AND INCREASE OF ANESTHESIA TIME FOR THE OBESE PATIENT, NO PATIENT INJURY WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046789 ↗
• MalfunctionApr 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE HF-RESECTION ELECTRODE, IS DEFORMED OR TWISTED AND THE COMBINATION WITH A WORKING ELEMENT IS NOT POSSIBLE OR THE FREEDOM OF MOVEMENT IN THE RESECTOSCOPE IS SEVERELY RESTRICTED. THE ISSUE WAS FOUND DURING A DIAGNOSTIC MYOMECTOMY PROCEDURE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE WIRE AT THE DISTAL END IS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16836839 ↗
• MalfunctionApr 27, 2023Break; Smoking; Break; Smoking

  IT WAS REPORTED TO OLYMPUS THAT AN HF-RESECTION ELECTRODE LOOP SUFFERED TOO MUCH MECHANICAL MANIPULATION AND WHEN ACTIVATED WITH THE HF ENERGY IT BROKE AND THERE WAS SMOKE. AN ENDOSCOPIC SEARCH WAS CARRIED OUT IN THE UTERINE CAVITY AND PIECES OF MATERIAL WERE FOUND. THE DEBRIS WAS ABLE TO BE RECOVERED FROM THE UTERINE CAVITY AND THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS A THERAPEUTIC HYSTEROSCOPY WHICH WAS COMPLETED USING A SIMILAR DEVICE. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828211 ↗