OlmypusRecalls & reported problems across all models

We found 3 models of Olmypus by OLYMPUS Winter & Ibe GmbH in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2022 and Jul 2, 2026 — classified as 8 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (25 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Olmypus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 11, 2025Open, Classified

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

   Z-1454-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 11, 2025Open, 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 Olmypus problems

Olmypus models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Olmypus WA22017A

  Resectoscope
  1 recall31 reports
• Olmypus A37004A

  Endoscope, Ac-Powered And Accessories
  1 recall0 reports
• Olmypus WA63728A

  Mediastinoscope, Surgical
  1 report

Recent Olmypus adverse event reports

The 15 most recent reports across all models, 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 ↗