USA Elite E123-ORecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925002371), received between Jan 6, 2021 and Aug 6, 2024 — 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.

• MalfunctionAug 6, 2024Crack; Crack

  THE CUSTOMER REPORTED TO OLYMPUS THE CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR TIP IS CRACKED. THE REPORTED ISSUE WAS DISCOVERED DURING PREPARATION OF USE FOR AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924487 ↗
• MalfunctionSep 2, 2022Crack; Crack

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A CRACK AT THE YELLOW TIP. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349234 ↗
• MalfunctionMay 26, 2022Break; Break

  CUSTOMER REPORTED WITH AN ISSUE OF " THE TIP IS BROKEN OFF". THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM , NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519880 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE HANDLE WAS FOUND DAMAGED, THE TIP WAS FOUND BROKEN. THERE WERE NO FURTHER DETAILS PROVIDED REGARDING THE REPORTED EVENT. NO PATIENT INVOLVEMENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11123259 ↗

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-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-2720-2026 · May 5, 2026 · Open, Classified
  Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
• 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-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-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