Olympus WA22017TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761051521), received between Apr 29, 2022 and Jul 14, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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. Nov 11, 2025Open, Classified

   Complaints of the ceramic tip of the resection sheath breaking have been received.

   Z-1451-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2024Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE BROKE OFF DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT). THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S BLADDER WITH A FORCEPS AND THE PATIENT'S HEALTH WAS NOT IMPACTED. THEY REPORTED THERE WAS UP TO A 10 MINUTE DELAY AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737692 ↗
• MalfunctionApr 29, 2022Break; Break

  THE CUSTOMER REPORTS DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE FOR THE INDICATION OF BLADDER CANCER USING A LONG INNER SHEATH, THE TIP OF THE SHEATH BROKE OFF. THE SURGEON FIRST WENT IN WITH THE INNER SHEATH, OUTER SHEATH, VISUAL OBTURATOR, AND 12DEG TELESCOPE. NEXT, THE SURGEON WENT IN WITH THE INNER/OUTER/WORKING ELEMENT/LOOP/12 DEGREE TELESCOPE. IT WAS FIRST VISUALIZED THAT THE SHEATH WAS BROKEN SHEATH ON THE THIRD INSERTION OF THE INSTRUMENTS INTO THE URETHRA. THE END APPEARED JAGGED ON THE MONITOR AND THE DEVICE WAS REMOVED AND INSPECTED. THE STAFF DIDN¿T OBSERVE THE ACTUAL BREAKING. IT IS UNSURE IF THE SHEATH WAS BROKEN PRIOR TO USE OR WAS BROKEN DURING THE PROCEDURE. THE STAFF PRESUMED IT WAS BROKEN DURING THE PROCEDURES SINCE THE DEFECT WAS LARGE AND EASILY OBSERVABLE. ALSO NOTED, THE PATIENT HAD AN EXTREMELY HIGH BLADDER NECK WHICH IS WHY THE LONG RESECTION SET WAS REQUESTED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS OF THE END OF THE PROCEDURE. THE PHYSICIAN DID NOT OBSERVE AND CUTS TO THE URETHRA THAT COULD BE FROM THE JAGGED EDGE OF THE BROKEN INSULATING TIP TO THE SHEATH. INSPECTION OF BLADDER DIDN¿T REVEAL ANY TRAUMA EITHER. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249627 ↗