Elite 2 System E2RIS-CF25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925003484), received between Apr 23, 2021 and Mar 25, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K890328); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE EXHIBITED BROKEN TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688497 ↗
• MalfunctionFeb 17, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THIS ROTATING CF RESECTOSCOPE INNER SHEATH WAS FOUND BROKEN DURING REPROCESSING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400702 ↗
• MalfunctionDec 10, 2021Component Missing; Component Missing

  AS REPORTED, THE RESECTOSCOPE IS MISSING THE CERAMIC TIP. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT INVOLVEMENT /HARM OR INJURY ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981376 ↗
• MalfunctionApr 23, 2021Material Separation; Material Separation

  IT IS REPORTED THE PATIENT UNDERWENT A TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) USING AN ERIS-CF25 ROTATING CF RESECTOSCOPE INNER SHEATH FOR THE INDICATION OF BLADDER CANCER. THERE WERE NO CHALLENGES WITH THE PATIENT'S ANATOMY. THERE WERE NO KNOWN COMPLICATIONS DURING THIS PROCEDURE. FOUR MONTHS AND 17 DAYS LATER, THE PATIENT UNDERWENT A SECOND PLANNED TURBT USING AN ERIS-CF25 ROTATING CF RESECTOSCOPE INNER SHEATH FOR THE INDICATION OF BLADDER CANCER. DURING THE SECOND TURBT PROCEDURE, TWO DEVICE FRAGMENTS FROM WHAT APPEARED TO BE THE ERIS-CF25 ROTATING CF RESECTOSCOPE INNER SHEATH USED IN THE FIRST PROCEDURE WERE FOUND. THE DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT WITHOUT ISSUE OR DELAY IN THE PLANNED PROCEDURE. THE PHYSICIAN STATED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE RETAINED FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K890328. One submission often covers many models, so check the product and lot details in each record.

• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-2720-2026 · May 5, 2026 · Open, Classified
  Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
• Z-2139-2025 · Jun 18, 2025 · Open, Classified
  Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some
• Z-2140-2025 · Jun 18, 2025 · Open, Classified
  Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the work
• Z-0568-2024 · Oct 2, 2023 · Open, Classified
  ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF M
• Z-1952-2018 · Apr 17, 2018 · Terminated
  Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs t