USA Elite EIS-HCF25Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00821925001893), received between Jul 10, 2020 and Mar 23, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659931 ↗
• MalfunctionMar 26, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701605 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE HAD A BROKEN TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162374 ↗
• MalfunctionNov 6, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE CF RESECTOSCOPE INNER SHEATH, 25FR HAS A BROKEN, MISSING TIP. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081341 ↗
• MalfunctionOct 11, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CF RESECTOSCOPE INNER SHEATH, 25FR HAD A DAMAGED TIP. THE EVENT OCCURRED DURING REPROCESSING FOR A THERAPEUTIC PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911583 ↗
• MalfunctionSep 4, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE CF RESECTOSCOPE INNER SHEATH, HAD A BROKEN TIP. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680574 ↗
• MalfunctionAug 22, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHILE REPROCESSING HIS OLYMPUS CF RESECTOSCOPE INNER SHEATH, THE TIP BROKE OFF. THIS EVENT HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596449 ↗
• MalfunctionJul 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE TIP OF THE SHEATH WAS DAMAGED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322556 ↗
• MalfunctionMay 30, 2023Break; Mechanical Problem; Break; Mechanical Problem

  DAMAGED TIP WAS REPORTED ON THE DEVICE . THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED. DEVICE RETURN EVALUATION FOUND BROKEN TIP , SHARP. THIS REPORT IS BEING SUBMITTED DUE TO THE FINDING OF BROKEN TIP , SHARP IDENTIFIED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021076 ↗
• MalfunctionMay 24, 2023Break; Break

  THE CUSTOMER RETURNED THE RESECTOSCOPE INNER SHEATH, TO OLYMPUS REPAIR CENTER FOR EVALUATION OF A BROKEN CERAMIC TIP THAT WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995214 ↗
• MalfunctionMay 17, 2023Crack; Crack

  IT WAS REPORTED THE DEVICE HAD A BROKEN TIP. THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED ISSUE. NO HARM, NO USER INJURY REPORTED. DEVICE EVALUATION FOUND CRACKED BEAK (TIP). THIS REPORT IS BEING SUBMITTED DUE TO THE FINDING OF CRACKED BEAK (TIP) DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950877 ↗
• MalfunctionMar 31, 2023Break; Crack; Break; Crack

  CUSTOMER REPRESENTATIVE REPORTED THE DEVICE CERAMIC TIP WAS BROKEN. THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED. NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654143 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  THE CUSTOMER REPORTED THE CERAMIC TIP OF THE SUBJECT DEVICE BROKE DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380420 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  THE CUSTOMER REPORTED THE CERAMIC TIP OF THE SUBJECT DEVICE BROKE DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380407 ↗
• MalfunctionFeb 15, 2023Crack; Crack

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A DAMAGED TIP ON THE CF RESECTOSCOPE INNER SHEATH (25FR). THE ISSUE OCCURRED DURING REPROCESSING, AND THERE WAS NO PATIENT HARM OR PROCEDURAL IMPACT ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND THE BEAK WAS BROKEN WITH MISSING SEGMENTS, AND THE METAL SHEATH TUBE WAS CRACKED AND DENTED AT THE PROXIMAL END CONNECTING WITH THE LOCKING MECHANISM. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378031 ↗
• MalfunctionFeb 8, 2023Break; Break

  CUSTOMER REPORTED WITH AN ISSUE OF THE "INNER SHEATH DAMAGED TIP". THE ISSUE OCCURRED DURING REPROCESSING. ACCORDING TO THE REPORT, THE DAMAGE WAS NOTICED WHILE REPROCESSING THE ITEM AND WAS RECEIVED IN THE DEPARTMENT WITHOUT ANY PATIENT INFORMATION OR ISSUES WITH THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16319736 ↗
• MalfunctionJan 20, 2023Break; Break

  OLYMPUS REPORTED ON BEHALF OF THE CUSTOMER, THE RESECTOSCOPE INNER SHEATH TIP BROKE DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219605 ↗
• MalfunctionJan 12, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A BROKEN TIP WHILE USING THE CF RESECTOSCOPE INNER SHEATH, 25FR. THE ISSUE OCCURRED DURING REPROCESSING, AND THERE WAS NO PROCEDURAL IMPACT OR PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146325 ↗
• MalfunctionJan 12, 2023Break; Mechanical Problem; Break; Mechanical Problem

  COMPANY REPRESENTATIVE REPORTED WITH AN ISSUE OF " BROKEN TIP". THE ISSUE OCCURRED DURING REPROCESSING. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. NO HARM REPORTED, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16144130 ↗
• MalfunctionJan 12, 2023Crack; Crack

  COMPANY REPRESENTATIVE SENT A REPAIR REQUEST REPORTED WITH AN ISSUE OF "INNER SHEATH DAMAGED, BROKEN TIP". THE ISSUE OCCURRED DURING REPROCESSING. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143933 ↗
• MalfunctionSep 12, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TIP IS CHIPPING. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406733 ↗
• MalfunctionAug 3, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CERAMIC TIP BROKE IN TO MULTIPLE PIECES. THE REPORTED PROBLEM WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160268 ↗
• MalfunctionMar 15, 2022Break; Break

  THE CUSTOMER REPORTED THE INNER SHEATH TIP BROKE ON THEIR CF RESECTOSCOPE INNER SHEATH, 25FR. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS. THERE WERE NO REPORTS OF DEATH, HARM OR INJURIES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773090 ↗
• MalfunctionDec 10, 2021Crack; Component Missing; Crack; Component Missing

  CUSTOMER UPDATES ON THE EVENT REPORTED AS BELOW: THE MISSING CERAMIC WAS LOCATED IN THE CYSTO DRAPES AT THE END OF THE PROCEDURE. THE SCRUB TECHNICIAN NOTICED IT WAS MISSING AT THE END OF THE CASE. SCRUB TECH FOUND THE MISSING TIP IN THE CYSTO DRAPES IN TWO SEPARATE PIECES AFTER IT WAS NOTICED THE TIP WAS MISSING FROM RESECTOSCOPE. NO HARM , NO PATIENT IMPACT. BROKEN TIP WAS NOT INSIDE THE PATIENT. THE DOCTOR WAS NOTIFIED TIP FOUND IN DRAPES. THE PATIENT WAS CHECKED (RE-SCOPE) TO ENSURE NO PIECES WERE LEFT INSIDE THE BLADDER. NOTHING FOUND INSIDE THE BLADDER. THE INTENDED PROCEDURE WAS COMPLETED. PROCEDURE PERFORMED WAS TUR-BUTTON TURP (TRANSURETHRAL RESECTION OF THE PROSTATE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981234 ↗
• MalfunctionJul 10, 2020Break; Break

  THE SERVICE CENTER WAS INFORMED THAT AT THE CONCLUSION OF A THERAPEUTIC PROCEDURE, THE BLACK DISTAL TIP OF THE INNER SHEATH CRACKED INTO TWO PIECES AND FELL INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT¿S BLADDER. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257393 ↗

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-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