Olympus A22053ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761021043), received between Apr 15, 2024 and Apr 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

18 other recalls cover devices cleared under the same FDA submission (K931994, K931995); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED, THE IRRIGATION PORT HAD BROKEN PLASTIC AT COUPLING. THE ISSUE WAS FOUND AFTER AN UNSPECIFIED OPERATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF ANY DELAY. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K931994, K931995. One submission often covers many models, so check the product and lot details in each record.

• Z-1451-2026 · Nov 11, 2025 · Open, Classified
  Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
• Z-1439-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
• Z-1453-2026 · Nov 11, 2025 · Open, Classified
  Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
• Z-1440-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
• Z-1448-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
• Z-1455-2026 · Nov 11, 2025 · Open, Classified
  Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
• Z-1457-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
• Z-1452-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
• Z-1443-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
• Z-1444-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
• Z-1447-2026 · Nov 11, 2025 · Open, Classified
  Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
• Z-1442-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
• Z-1450-2026 · Nov 11, 2025 · Open, Classified
  Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
• Z-1445-2026 · Nov 11, 2025 · Open, Classified
  Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
• Z-1456-2026 · Nov 11, 2025 · Open, Classified
  Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

…and 3 more.