Olympus A22014ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04042761020893), received between Jun 21, 2018 and Jun 19, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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-1438-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT BLACK FRAGMENTS FROM THE SCOPE BROKE OFF INSIDE THE PATIENT DURING A CYSTOSCOPY WITH TURBT, BLADDER TUMOR REMOVAL, AND STONE EXTRACTION INVOLVING AN OLYMPUS RIGID ENDOSCOPE SHEATH. THE CUSTOMER DID NOT PROVIDE A SUSPECTED CAUSE. ALL THE PIECES WERE REMOVED FROM THE PATIENT, AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566641 ↗
• MalfunctionFeb 6, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282839 ↗
• InjurySep 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057681 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THE CERAMIC HEAD OF THE RESECTION SHEATH WAS BROKEN. THE EVENT WAS OBSERVED DURING SERVICE/MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210315 ↗
• MalfunctionApr 26, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE CERAMIC TIP ON THE RIGID ENDOSCOPE SHEATH WAS LOOSE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190622 ↗
• MalfunctionApr 22, 2022Break; Break

  THE CUSTOMER REPORTED THE CERAMIC TIP FROM THE RESECTION SHEATH, 24 FR INTERMITTENT IRRIGATION BROKE OFF INTRAOPERATIVELY DURING A TRANSURETHRAL RESECTION OF A PROSTATE AND LASER LITHOTRIPSY PROCEDURE. THE FRAGMENT WAS RETRIEVED FROM THE BLADDER. THE ENTIRE PIECE WAS RETRIEVED WITHOUT INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14184467 ↗
• MalfunctionNov 12, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT AFTER CLEANING, AFTER AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH WAS DAMAGED AND THAT A FRAGMENT HAD BROKEN OFF. IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED AND WHETHER A FRAGMENT POSSIBLY FELL INTO A PATIENT'S BODY CAVITY. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309804 ↗
• MalfunctionNov 4, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED RESECTION PROCEDURE AT AN UNKNOWN DATE, THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH BROKE OFF AND FELL INSIDE THE PATIENT¿S BLADDER. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9271276 ↗
• MalfunctionJun 25, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT AFTER CLEANING/REPROCESSING FOLLOWING AN UNSPECIFIED THERAPEUTIC RESECTION PROCEDURE AT AN UNKNOWN DATE, A FRAGMENT OF CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH WAS FOUND TO HAVE BROKEN OFF AND IS MISSING. IT IS UNKNOWN WHETHER THIS HAPPENED DURING THE PROCEDURE OR DURING REPROCESSING. 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 8730343 ↗
• MalfunctionJun 25, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE BLADDER (TURB) PROCEDURE, THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH BROKE OFF AND FELL INSIDE THE PATIENT¿S BLADDER. SINCE THE PATIENT SUFFERS FROM A URETHRAL STRICTURE, THE FRAGMENT COULD NOT BE RETRIEVED. THEREFORE, THE INTENDED PROCEDURE WAS CANCELED AND A FOLLOW-UP PROCEDURE WILL BE SCHEDULED FOR REMOVAL OF THE FRAGMENT. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7633015 ↗
• MalfunctionJun 21, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED CYSTOSCOPY PROCEDURE, THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH BROKE OFF AND FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624079 ↗