Olympus WA22503DRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 14042761068205), received between Apr 18, 2019 and Jul 13, 2026 — classified as 6 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Break; Material Fragmentation

  IT WAS REPORTED THE RESECTION ELECTRODE, HAD THE INTRAOPERATIVE BREAKAGE OF THE LOOP ELECTRODE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25799927 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS BROKEN. THE ISSUE OCCURRED DURING SET UP FOR A THERAPEUTIC UROLOGY RESECTION 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 25150286 ↗
• MalfunctionJun 11, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187628 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE HAD A PART OF THE ELECTRODE FALL OFF IN THE PATIENT'S BLADDER. THE PATIENT WAS NOT AFFECTED AS THE PART EXITED THE BODY WITH THE IRRIGATION FLUID. THE EVENT OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134304 ↗
• MalfunctionApr 30, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT UPON RECEIPT OR UNPACKING, THE HF-RESECTION ELECTRODE LOOP HAD DEFECTIVE ELECTRODE WHEN UNPACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935684 ↗
• MalfunctionJan 30, 2025Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED, THAT THE HF-RESECTION ELECTRODE MADE LARGE SPARKS AND DID NOT CUT. THE DEVICE WAS USED FOR BLADDER RESECTIONS IN TWO DIFFERENT ROOMS. IT WAS NOTED THAT THE DEVICE MADE ABNORMAL NOISE CONTINUOUSLY AND SMOKED AND TURNED BLACK. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276154 ↗
• MalfunctionJan 29, 2025Thermal Decomposition of Device; Sparking; Thermal Decomposition of Device; Sparking

  IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD BIG SPARKS AND CHARRED THEN TURNED BLACK. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263628 ↗
• MalfunctionJan 28, 2025Failure to Cut; Sparking; Failure to Cut; Sparking

  IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE SHACKLE WAS UNABLE TO CUT AND MADE LARGE SPARK. THE ISSUE OCCURRED DURING A BLADDER RESECTION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260432 ↗
• MalfunctionJan 28, 2025Failure to Cut; Sparking; Failure to Cut; Sparking

  NO ADDITIONAL INFORMATION FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256442 ↗
• MalfunctionJan 28, 2025Thermal Decomposition of Device; Sparking; Thermal Decomposition of Device; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254398 ↗
• MalfunctionJan 28, 2025Failure to Cut; Sparking; Failure to Cut; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252732 ↗
• MalfunctionJan 28, 2025Thermal Decomposition of Device; Sparking; Thermal Decomposition of Device; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252286 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NO DEFECT WITH THE OLYMPUS DEVICES, AND THE DEVICES WERE FUNCTIONING PROPERLY. ADDITIONALLY, IN A DISCUSSION WITH THE OPERATION MANAGER (WHO WAS PRESENT DURING THE OPERATION), IT IS NOT BELIEVED THAT AN OLYMPUS DEVICE COULD HAVE CAUSED THE OXYHYDROGEN EXPLOSION. ALL THE DEVICES WERE INSPECTED PRIOR TO USE AND THE MAINTENANCE INTERVALS HAD BEEN ADHERED TO IN ACCORDANCE WITH THE LAW. FURTHERMORE, THE HOSES USED WERE ALSO NOT LEAKING. THE CUSTOMER NOTED, "THE EXPLOSION OF OXYHYDROGEN GAS IS A VERY RARE RISK IN THIS OPERATION, WHICH HAS NOTHING TO DO WITH THE DEVICES USED.".

  Patient problems: Internal Organ Perforation

  MAUDE report 20339193 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 30 MINUTES AFTER BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE IN SALINE (TURPIS-P) THE PATIENT WAS BLEEDING AND IT WOULD NOT STOP; THEREFORE, SURGICAL MANAGEMENT WAS REQUIRED. IT WAS LATER REPORTED THE PATIENT RETURNED HOME THAT SAME DAY.

  Patient problems: Genital Bleeding; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19160007 ↗
• MalfunctionMar 28, 2024Melted; Melted

  IT WAS REPORTED, THE HIGH FREQUENCY-RESECTION ELECTRODE, WAS NOT WORKING AS IT WAS NOT COAGULATING. THE DOCTOR FOUND OUT THE LOOP WAS BROKEN AND REPLACED THE LOOP WITH AN ELECTRODE ROLLER BALL. WHILE DOING THE REPLACEMENT, AN ATTEMPT WAS MADE TO REMOVE THE LOOP, AND IT WAS EVIDENT THAT THE ELECTRODE HAS MELTED AND WAS STUCK. THE ELECTRODE LOOP WAS PULLED OUT USING FORCE. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE FOR A HYSTEROSCOPIC TRANSCERVICAL RESECTION OF MYOMA (TCRM) AND LAP MYOMECTOMY. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991073 ↗
• MalfunctionMar 5, 2024Material Rupture; Output Problem; Material Rupture; Output Problem

  IT WAS REPORTED THAT WHILE USING THE HIGH-FREQUENCY RESECTION ELECTRODE DURING A HYSTEROSCOPY RESECTION (PATIENT UNDER SPINAL ANESTHESIA) THERAPEUTIC PROCEDURE, IT WAS OBSERVED THAT THERE WAS A RUPTURE TO THE TERMINAL PART OF THE SINGLE-USE RESECTION LOOP. THE PATIENT BUTTOCKS ABRUPTLY MOVED AND SHE EXPERIENCED PAIN WITHOUT AN ERROR MESSAGE BEING SEEN ON THE GENERATOR. THE PATIENT THEN COMPLAINED OF A METALLIC TASTE IN HER MOUTH. THE PROCEDURE WAS STOPPED, AND WHEN THE LOOP WAS REMOVED, THERE WAS A RUPTURE IN THE TERMINAL PART OF THE LOOP. THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED DEVICE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839143 ↗
• MalfunctionJan 12, 2024Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN ELECTRIC ARC RESECTION UNDER GENERAL ANESTHESIA, A CYSTOSCOPY AND LATER A URETEROSCOPY WAS PERFORMED WITH A RIGID ENDOSCOPE. THE RESECTION IN BLADDER WAS COMPLETED USING A SINGLE USE BIPOLAR LOOP. REPORTEDLY THE LOOP WAS DEFORMED AND THE ELECTRIC CURRENT DIFFUSED INTO THE PATIENT AND SHOCKED THE PATIENT AND THERE NO MORE VISION ON THE OPTICS. THIS CAUSED THE PATIENT TO STARTLE WITH HYPERTENSION OF 180 SYSTOLE FOR 15 MINUTES AND TACHYCARDIA -115 BPM. THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE ELECTRIC SHOCK. IT WAS REPORTED THAT THERE WERE NO PATIENT SEQUELAE AT THE MOMENT AND PATIENT WAS STILL WAKING UP DURING THE CALL. THERE IS NO REPORT THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE MALFUNCTION CAUSED OR CONTRIBUTED TO A PERMANENT IMPAIRMENT IN THE PATIENT.

  Patient problems: Hyperextension; Tachycardia

  MAUDE report 18502754 ↗
• MalfunctionDec 14, 2023Electrostatic Discharge; Electrostatic Discharge

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE WAS IN USE WHEN THE DOCTOR SAW AN ELECTRIC ARC BETWEEN TWO HIGH FREQUENCY CABLE ATTACHMENT PINS FROM THE RESECTOSCOPE. THE DOCTOR WAS NOT AFFECTED AND DID NOT FEEL ANYTHING. THE ISSUE WAS FOUND DURING A PROSTATE OPERATION. THE EQUIPMENT WAS CHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW SET OF DEVICES. THE PROCEDURE WAS EXTENDED FOR 20 MINUTES WITH THE PATIENT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) (WA22366A - WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6) (ESG-400 - HF-UNIT), (B)(6) (WA00014A - HF-CABLE, BIPOLAR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326894 ↗
• InjuryNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE HF-RESECTION ELECTRODE, LOOP WAS DEFECTIVE INTRAOPERATIVELY. DURING AN ATTEMPT TO REMOVE A CORPUS POLYP OF ABOUT 1 CM IN SIZE, IT WAS SUDDENLY DISCOVERED THAT HALF OF THE NOSE WAS MISSING. THE MISSING PART COULD NOT BE FOUND. THE NOSE HAD NOT BEEN TAMPERED WITH OR TAMPERED WITH BEFORE. THE PATIENT HAS HAD AN ABDOMINAL X-RAY, BUT NO OTHER CONSEQUENCES. THE RESECTOSCOPE WAS EXAMINED BY REPROCESSING AND NO DEFECT IN THE INSULATION WAS FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, DESPITE THE DEFECT. THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, AND THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150197 ↗
• InjuryOct 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN INTRACAVITARY RESECTION PROCEDURE, THE RESECTION ELECTRODE LOOP HAD BEEN DEFORMED AND BENT. A SECOND ONE WAS USED BUT BROKE AND REMAINED STUCK IN THE PATIENT'S UTERINE POLYP, WHICH THE CUSTOMER WAS UNABLE TO RECOVER. THE PATIENT HAD BLEEDING BUT RECUPERATED AFTERWARDS. NO PROLONGED HOSPITALIZATION. THE PROCEDURE WAS DELAYED FOR TEN MINUTES AND WAS NOT COMPLETED. THE PATIENT WILL HAVE A NEW PROCEDURE - HYSTERECTOMY. THE DEVICES WERE INSPECTED BEFORE USE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. TWO REPORTS WERE REQUIRED FOR THIS EVENT WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - 1ST RESECTION ELECTRODE LOOP; (B)(6) - 2ND RESECTION ELECTRODE LOOP. THIS REPORT IS FOR (B)(6).

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17914338 ↗
• InjuryOct 11, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN INTRACAVITARY RESECTION PROCEDURE, THE RESECTION ELECTRODE LOOP HAD BEEN DEFORMED AND BENT. A SECOND ONE WAS USED BUT BROKE AND REMAINED STUCK IN THE PATIENT'S UTERINE POLYP, WHICH THE CUSTOMER WAS UNABLE TO RECOVER. THE PATIENT HAD BLEEDING BUT RECUPERATED AFTERWARDS. NO PROLONGED HOSPITALIZATION. THE PROCEDURE WAS DELAYED FOR TEN MINUTES AND WAS NOT COMPLETED. THE PATIENT WILL HAVE A NEW PROCEDURE - HYSTERECTOMY. THE DEVICES WERE INSPECTED BEFORE USE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. TWO REPORTS WERE REQUIRED FOR THIS EVENT WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - 1ST RESECTION ELECTRODE LOOP. (B)(6) - 2ND RESECTION ELECTRODE LOOP. THIS REPORT IS FOR (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17914168 ↗
• MalfunctionSep 7, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE LOOP ON A HF-RESECTION ELECTRODE, LOOP, BENT AND BROKE EASILY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697603 ↗
• MalfunctionAug 31, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER CONFIRMING THAT THE DEVICE ASSOCIATED WITH REPORT WITH PATIENT IDENTIFIER (B)(6) WAS DISPOSED OF AT THE HOSPITAL AND WILL NOT BE RETURNED. ADDITIONALLY, THE REMAINING DEVICES, ASSOCIATED WITH PATIENT IDENTIFIERS (B)(6) ARE BEING RETURNED TO OLYMPUS FOR EVALUATION. THE RESULTS OF THOSE EVALUATIONS WILL BE INCLUDED ON EACH FINAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662077 ↗
• MalfunctionAug 31, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHILE PERFORMING A TRANSURETHRAL RESECTION PROSTATE PROCEDURE WITH AN OLYMPUS HF-RESECTION ELECTRODE DEMO DEVICE, THE WELDING SPOT AT THE LOOP BROKE OFF. ACCORDING TO THE INITIAL REPORTER, THE ALARM MESSAGE ¿I0002: SHORT CIRCUIT¿ APPEARED ON THE DISPLAY. REPORTEDLY, THE LOOP WAS CHANGED OUT, AND THE NEW ONE BROKE IMMEDIATELY. THE CUSTOMER CONFIRMED THAT A TOTAL OF 3 LOOPS WERE DAMAGED IN THIS WAY. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS 2 OF 3. PLEASE SEE REPORTED WITH PATIENT IDENTIFIERS (B)(6) FOR THE RELATED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662009 ↗
• MalfunctionAug 31, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHILE PERFORMING A TRANSURETHRAL RESECTION PROSTATE PROCEDURE WITH AN OLYMPUS HF-RESECTION ELECTRODE DEMO DEVICE, THE WELDING SPOT AT THE LOOP BROKE OFF. ACCORDING TO THE INITIAL REPORTER, THE ALARM MESSAGE ¿I0002: SHORT CIRCUIT¿ APPEARED ON THE DISPLAY. REPORTEDLY, THE LOOP WAS CHANGED OUT, AND THE NEW ONE BROKE IMMEDIATELY. THE CUSTOMER CONFIRMED THAT A TOTAL OF 3 LOOPS WERE DAMAGED IN THIS WAY. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS 1 OF 3. PLEASE SEE REPORTED WITH PATIENT IDENTIFIERS (B)(6) FOR THE RELATED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661903 ↗