Olympus WA22355CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 14042761030615), received between Sep 4, 2018 and Oct 23, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT WHEN PREPARING FOR SURGERY IN THE OPERATING ROOM, THE TIP OF THE RESECTION ELECTRODE DEVICE WAS FOUND TO BE BROKEN AFTER UNPACKING. IT WAS REPLACED WITH A NEW ONE FOR SURGERY, AND THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516774 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HIGH FREQUENCY RESECTION ELECTRODE EXHIBITED THE DISTAL END WIRE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130230 ↗
• MalfunctionAug 27, 2024Break; Break

  THE CUSTOMER REPORTED THE DISTAL END OF THE RESECTION ELECTRODE BROKE. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074269 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED, THE HF-RESECTION ELECTRODE'S LOOP AT THE TIP WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605570 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A PLANNED LASER PROSTATE RESECTION ON (B)(6) 2023, A NON-OLYMPUS LASER WAS BEING USED INITIALLY BUT DUE TO SOME TECHNICAL ISSUE WITH THE LASER EQUIPMENT, THE DOCTOR USED THE OLYMPUS RESECTION SET WITH A NON-OLYMPUS KNIFE. AFTER USING THE DEVICE FOR NEARLY 20 TO 25 MINUTES, THE DOCTOR HAD SHIFTED TO A DIFFERENT NON-OLYMPUS LASER AND COMPLETED THE PROCEDURE WITH NO COMPLICATIONS AT THAT POINT. AT A LATER DATE ON (B)(6) 2023, THE CATHETER WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS OKAY AT THAT TIME. ON (B)(6) 2023, THE PATIENT HAD A FOLLOW-UP VISIT AND PER THE DOCTOR THE PATIENT WAS FINE. ON (B)(6) 2023, THE PATIENT NOTICED A "URINE LEAK" AND NOTIFIED A DOCTOR. ON (B)(6) 2023, THE OPERATING DOCTOR BECAME AWARE AND RECEIVED PICTURES THAT THE PATIENT PROVIDED. THE DOCTOR ADVISED FOR A NEEDED URETHRAL RECONSTRUCTION AND NO OTHER COMPLICATIONS. THIS EVENT REQUIRES 6 REPORTS. RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) / MODEL: WB91051W / SN: (B)(6). (B)(6) / MODEL: WA22366A / SN: (B)(6). (B)(6) / MODEL: A22040A / SN: (B)(6). (B)(6) / MODEL: A22026A / SN: (B)(6). (B)(6) / MODEL: WA22355C SN: UNKNOWN. (B)

  Patient problems: Urinary Incontinence

  MAUDE report 18040521 ↗
• InjuryAug 3, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE HIGH FREQUENCY-RESECTION ELECTRODE, 45° NEEDLE, SINGLE USE DISTAL END WIRE BROKE. THE ISSUE OCCURRED DURING A DIAGNOSTIC HYSTEROSCOPY AND CURETTAGE. DURING THE OPERATION, DEVICE WAS CUTTING A NEOPLASM WHEN THE WIRE AT THE DISTAL END BROKE, LEADING TO INCREASED BLEEDING AND PROLONGED SURGERY TIME WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO ADDITIONAL REPORTS OF PATIENT IMPACT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17451426 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "EN BLOC RESECTION VERSUS CONVENTIONAL TURBT FOR T1HG BLADDER CANCER: A PROPENSITY SCORE-MATCHED ANALYSIS." THIS STUDY AIMED TO CLARIFY THE PERIOPERATIVE, ONCOLOGIC, AND PATHOLOGIC OUTCOMES OF EN BLOC RESECTION OF BLADDER TUMORS (ERBT) FOR PATIENTS WITH PT1 BLADDER CANCER (BCA) COMPARED WITH CONVENTIONAL TRANSURETHRAL RESECTION OF BLADDER TUMORS (CTURBT) IN A LARGE MULTICENTER RETROSPECTIVE COHORT USING PROPENSITY SCORE-MATCHED (PSM) ANALYSIS. THE PSM COHORT CONSISTED OF 202 PATIENTS: 101 IN CTURBT GROUP AND 101 IN ERBT GROUP. COMPLICATIONS WERE DETECTED IN SIX PATIENTS IN THE CTURBT GROUP AND FOUR PATIENTS IN THE ERBT GROUP. THE 3-YEAR RFS ESTIMATES WERE 59.3% [95% CONFIDENCE INTERVAL (CI) 48.2¿68.8] IN THE CTURBT GROUP, AND 65.8% (95% CI 54.0¿75.2) IN THE ERBT GROUP (P = 0.7). THERE WERE NO DIFFERENCES IN THE 3-YEAR MFS AND THE 3-YEAR CSS ESTIMATES BETWEEN THE TWO GROUPS. THE DETECTION RATE FOR MM¿VP WAS SIGNIFICANTLY HIGHER IN PATIENTS WHO UNDERWENT ERBT (CTURBT: 77% VERSUS ERBT: 99%, P\0.001). ERBT IMPROVES THE QUALITY OF RESECTION AND SPECIMEN, YIELDING LESS RESIDUE ON RETUR AND YIELDING SUPERIOR HISTOPATHOLOGIC INFORMATION SUC

  Patient problems: Perforation

  MAUDE report 17393606 ↗
• MalfunctionJul 12, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, WHILE PREPARING FOR A THERAPEUTIC RESECTION CASE IT WAS FOUND THAT THE NEEDLE OF THE ELECTRODE WAS LOOSE DUE TO AN INTERNAL MECHANISM ISSUE, RENDERING IT UNABLE TO USE. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313378 ↗
• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING PREPARATION FOR A TURIS RESECTION THE HF-RESECTION ELECTRODE NEEDLE WAS BENDING DUE TO AN INTERNAL MECHANISM ISSUE. THIS ISSUE RENDERED THE DEVICE UNABLE TO CUT AND WAS NOT USED ON THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806197 ↗
• MalfunctionApr 24, 2023Arcing; Arcing

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC UROLOGY PROCEDURE, WHEN THE HIGH FREQUENCY RESECTION ELECTRODE DEVICE WAS USED WITH THE GENERATOR, AN ELECTRICAL ARC OCCURRED. SECOND ATTEMPT WITH THE DEVICE REPEATED THE ELECTRICAL ARC. THE PHYSICIAN THEN SWITCHED BACK TO MONOPOLAR WITH A MONOPOLAR LOOP AND GLYCOCOLLE. THE PROCEDURE WAS COMPLETED WITH SOME DELAY. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THIS WAS THE FIRST DEVICE USED ON THIS PATIENT. HOWEVER, OTHER DEVICES FROM THE BOX HAD BEEN USED IN OTHER PROCEDURES WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799571 ↗
• MalfunctionSep 5, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC HYSTEROSCOPY PROCEDURE, THE NEEDLE TIP AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND A FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845908 ↗
• MalfunctionSep 4, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED HYSTEROSCOPIC PROCEDURE, THE NEEDLE TIP AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND A FRAGMENT FELL INSIDE THE PATIENT. THE PATIENT WAS THEN X-RAYED AND THE FRAGMENT RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841350 ↗