USA Elite EMRS-26BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821925001992), received between May 4, 2022 and Mar 24, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE HAD A INSTRUMENT TIP IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681606 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT THE HYSTEROSCOPE HAD A BROKEN CERAMIC TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899000 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC TOP OF THE SUBJECT DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657343 ↗
• MalfunctionNov 13, 2024Dent in Material; Dent in Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTOSCOPE EXHIBITED DENTED PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677561 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED, THE SHEATH'S CERAMIC TIP WAS BROKE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822147 ↗
• MalfunctionDec 15, 2023Crack; Crack

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE NON-CF RESECTOSCOPE METAL BROWN BEAK SHEATH HAD THE CERAMIC AT THE END CRACK. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334126 ↗
• MalfunctionAug 3, 2022Break; Break

  CUSTOMER REPORTED WITH AN ISSUE OF " BROKEN WHITE END". THE ISSUE FOUND 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 15161715 ↗
• MalfunctionJul 27, 2022Break; Break

  A USER FACILITY REPORTED THAT THE WHITE CHIP AT THE END OF THE METAL SHEATH OF A SCOPE BROKE OFF. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112716 ↗
• MalfunctionMay 4, 2022Break; Break

  THE DEVICE WAS RETURNED FOR EVALUATION AND REPAIR FOR THE BREAKING OF THE WHITE TIP THAT OCCURRED DURING INSTALLATION. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14277656 ↗

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-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