Olmypus WA22017ARecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04042761051514), received between Mar 12, 2022 and Jul 2, 2026 — classified as 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 11, 2025Class IIOpen, Classified

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

   Z-1450-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Break

  THE CUSTOMER REPORTED THAT THE DEVICE TIP BROKE OFF AT THE DISTAL END, DEVICE OUTSIDE PATIENT. THIS OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE INVOLVING A RIGID ENDOSCOPE SHEATH, CAUSING A PROCEDURAL DELAY OF LESS THAN 30 MINUTES. THE INTENDED PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. NO PATIENT INJURY OR HARM WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700100 ↗
• MalfunctionJun 8, 2026Material Fragmentation

  THE CUSTOMER RETURNED THE RIGID ENDOSCOPE SHEATH, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE CERAMIC TIP IS BROKEN. THE INVESTIGATION CENTER ASSESSED THE CONDITION AND DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO STRESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425419 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE SHEATH WAS BROKEN. THE ISSUE WAS FOUND DURING REPROCESSING. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631185 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE HAD A BROKEN CERAMIC TIP. THE ISSUE WAS OBSERVED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324386 ↗
• InjuryJun 26, 2025Break; Break

  DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR, A PIECE OF THE INNER SHEATH BROKE OFF IN THE BLADDER. THE SHEATH WAS REMOVED AND EXCHANGED, THEN THE PHYSICIAN UTILIZED A GRASPER TO PULL OUT THE BROKEN SHEATH. THERE WAS NO TRAUMA NOTED IN THE BLADDER OR THE URETHRA DURING EXTRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341366 ↗
• InjuryJun 26, 2025Break; Break

  DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR, A PIECE OF THE INNER SHEATH BROKE OFF IN THE BLADDER. THE SHEATH WAS REMOVED AND EXCHANGED, THEN THE PHYSICIAN UTILIZED A GRASPER TO PULL OUT THE BROKEN SHEATH. THERE WAS NO TRAUMA NOTED IN THE BLADDER OR THE URETHRA DURING EXTRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341297 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INNER SHEATH, LONG, THE CERAMIC TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326485 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF INNER SHEATH WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283047 ↗
• 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 19737697 ↗
• 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 19737696 ↗
• 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 19737693 ↗
• MalfunctionJul 9, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SHEATH EXHIBITED A BROKEN BEAK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705006 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THE REUSABLE ENDOSCOPE SHEATH HAD A CHIP OUT OF THE TIP OF THE INSTRUMENT. THE ISSUE OCCURRED DURING UNBOXING AND WAS AN OUT OF BOX FAILURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552673 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED, THE INNER SHEATH, LONG, FOR WA22018A AND WA22019A EXHIBITED A BROKEN CERAMIC TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381523 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT PLASTIC PIECES BROKE OFF FROM THE BOTTOM OF THE ENDOSCOPE SHEATH. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352830 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED, THE RIGID ENDOSCOPE SHEATH TIP BROKE OFF ON THE INNER SHEATH. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856146 ↗
• MalfunctionOct 20, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE INNER SHEATH, LONG, WAS BROKEN. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CERAMIC TIP WAS CRACKED. 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 17972669 ↗
• MalfunctionOct 6, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE SHEATH WAS BROKEN. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17888793 ↗
• MalfunctionOct 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER RETURNED THE INNER (RESECTOSCOPE) SHEATH TO OLYMPUS FOR A REPORTED ¿REPAIR NEEDED¿. THERE WAS NO DEFECT OR MALFUNCTION SPECIFIED. HOWEVER, DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE CERAMIC INSULATION AT THE DISTAL TIP OF THE SHEATH WAS MISSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878273 ↗
• InjuryAug 8, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THE PROCEDURE, THE CERAMIC TIP ON THE INNER SHEATH BROKE OFF IN THE PATIENT. THE PATIENT WAS LARGE WITH A VERY LARGE PROSTATE AND ELEVATED BLADDER NECK. VISIBILITY WAS POOR DUE TO BLEEDING. THE DOCTOR WAS PUTTING A LOT OF TORQUE ON THE SCOPE AND THE SHEATH AND DAMAGED THE SHEATH IN THE PROCESS. WHEN THE SHEATH WAS REMOVED, IT WAS NOTICED IT WAS BROKEN. THE DOCTOR WAS INFORMED THAT THE PIECE NEEDED TO BE RETRIEVED, AND HE STATED HE COULD NOT AT THAT TIME AND HE WOULD RETRIEVE IT WHEN THE PATIENT CAME BACK FOR THE ROBOT PROSTATE. A CATHETER WAS INSERTED AND THE CASE WAS ABORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17484474 ↗
• InjuryAug 8, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THE PROCEDURE, THE CERAMIC TIP ON THE INNER SHEATH BROKE OFF IN THE PATIENT. THE PATIENT WAS LARGE WITH A VERY LARGE PROSTATE AND ELEVATED BLADDER NECK. VISIBILITY WAS POOR DUE TO BLEEDING. THE DOCTOR WAS PUTTING A LOT OF TORQUE ON THE SCOPE AND THE SHEATH AND DAMAGED THE SHEATH IN THE PROCESS. WHEN THE SHEATH WAS REMOVED, IT WAS NOTICED IT WAS BROKEN. THE DOCTOR WAS INFORMED THAT THE PIECE NEEDED TO BE RETRIEVED, AND HE STATED HE COULD NOT AT THAT TIME AND HE WOULD RETRIEVE IT WHEN THE PATIENT CAME BACK FOR THE ROBOT PROSTATE. A CATHETER WAS INSERTED AND THE CASE WAS ABORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17484472 ↗
• MalfunctionMay 18, 2023Break; Break

  THE ASSET INNER SHEATH WAS RETURNED AND EVALUATED. THERE WAS NO ALLEGATION OF A COMPLAINT. HOWEVER, UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOUND THE ISOLATION BEAK WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955383 ↗
• MalfunctionMay 15, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO OLYMPUS THAT AN INNER SHEATH HAD OPTICAL VISION ISSUES. THE VISION WAS TRUNCATED WHEN THE OPTIC WAS INSERTED IN THE INTERNAL SHEATH (CERAMIC OF THE VISIBLE SHEATH). THE DEVICE WAS SENT IN FOR EVALUATION AND REPAIR. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935107 ↗
• MalfunctionApr 8, 2023Break; Break

  THE CUSTOMER REPORTED THE END WAS FOUND BROKEN OFF THE INNER SHEATH, LONG DURING PREPARATION FOR USE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705108 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED DURING AN ASSET RETURN (LOANER) WITH NO ISSUES REPORTED FROM THE CUSTOMER FACILITY, UPON INSPECTION OF THE RETURN, IT WAS OBSERVED THAT THE DEVICE ISOLATION BEAK IS BROKEN. THERE WAS NO HARM REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569187 ↗