ENDOSCOPE REPROCESSOR OER-MINIRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170331619), received between Dec 22, 2022 and Apr 23, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (8 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 31, 2025Open, Classified

   Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

   Z-0874-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 26, 2023Open, Classified

   Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

   Z-2343-2023 · Root cause: Labeling Change Control · Recall details · 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.

• MalfunctionApr 23, 2026Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR PRESENTED SCOPES THAT HAD WHITE SPECKS ON THEM AFTER REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973703 ↗
• MalfunctionJan 20, 2026Device Reprocessing Problem

  NO NEW INFORMATION RECEIVED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116227 ↗
• MalfunctionOct 30, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE ENDOSCOPE REPROCESSOR WAS CONSTANTLY FILLING UP WITH WATER WHILE OUT OF OPERATION AND POWERED OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564187 ↗
• MalfunctionOct 22, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE ENDOSCOPE PREPROCESSOR EXHIBITED ISSUES RELATED TO WATER FLOW AND SLOW FILL TIMES. AFTER DETERMINING THAT THE PROBLEM WAS DUE TO SLOW WATER FILL TIMES, THE FIELD SERVICE ENGINEER (FSE) FACILITATED THE REPLACEMENT OF THE FILTERS. ALTHOUGH THE FILTERS WERE SLIGHTLY AHEAD OF THE REGULAR REPLACEMENT SCHEDULE, THE FSE NOTED THAT THE LAST FEW FILTER REPLACEMENTS HAD ALSO BEEN CARRIED OUT ABOUT A WEEK EARLIER THAN PLANNED. ONCE THE FILTERS WERE REPLACED, NO FURTHER ISSUES WITH THE UNIT'S DRAINING AND CHEMICAL LOADING WERE OBSERVED. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509810 ↗
• MalfunctionJul 10, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE ENDOSCOPE REPROCESSORS WATER FILTER CANNOT BE DISINFECTED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711687 ↗
• MalfunctionJun 12, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE ENDOSCOPE REPROCESSOR HAD FAILING TEST STRIPS. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519042 ↗
• MalfunctionMar 13, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THERE WAS A BLACK SPECK WITHIN THE BASIN, DURING USE OF THE ENDOSCOPE REPROCESSOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18898253 ↗
• MalfunctionOct 9, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS ADDITIONALLY REPORTED BY THE CUSTOMER THAT THE ISSUE WAS RESOLVED THE SAME DAY IT WAS REPORTED. THE FACILITY RAN ANOTHER CYCLE AND THE TEST STRIPS PASSED. NO PATIENTS WERE AFFECTED. IT WAS FURTHER CLARIFIED THAT NO SCOPES WERE PROCESSED UNTIL THE MATTER WAS FIXED, AND THERE WERE NO INFECTIONS/CONCERN FOR INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 17896544 ↗
• InjuryOct 9, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS ADDITIONALLY REPORTED BY THE CUSTOMER THAT THE ISSUE WAS RESOLVED THE SAME DAY IT WAS REPORTED. THE FACILITY RAN ANOTHER CYCLE AND THE TEST STRIPS PASSED. NO PATIENTS WERE AFFECTED. IT WAS FURTHER CLARIFIED THAT NO SCOPES WERE PROCESSED UNTIL THE MATTER WAS FIXED, AND THERE WERE NO INFECTIONS/CONCERN FOR INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 17896477 ↗
• MalfunctionJul 26, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT SHE HAD POTENTIALLY INADVERTENTLY USED INCORRECT REPROCESSING SOLUTION WHILE OPERATING HER OLYMPUS ENDOSCOPE REPROCESSOR. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT. HOWEVER, ADDITIONAL DETAILS CONCERNING THE POTENTIAL CONNECTION TO PATIENTS HAVE BEEN REQUESTED. THUS FAR, NO RESPONSES HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397173 ↗
• MalfunctionDec 22, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE ENDOSCOPE REPROCESSOR HAD A DAMAGED YELLOW CONNECTOR. THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035314 ↗