WASHING CASE MAJ-2121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170404153), received between Jun 28, 2023 and Jan 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K190969); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT THE CHAIN THAT CONNECTS THE LID TO THE WASHING CASE WAS MISSING. AS A RESULT, THE LID WAS NOT SECURED AND WAS MOVING FREELY INSIDE THE ENDOSCOPE REPROCESSOR DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981398 ↗
• MalfunctionJun 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE FIELD SERVICE ENGINEER (FSE) REPORTED TO OLYMPUS, THE WASHING CASE WAS BEING USED OFF LABEL. FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER'S FACILITY AND NOTICED THAT THE WASHING BASIN LIDS WERE REMOVED FROM THE WASHING BASIN CUP, FSE REATTACHED 3 OUT OF 4 WASHING BASIN LIDS AND THE CUSTOMER COULD NOT FIND THE 4TH LID AND WILL BE LOOKING FOR THE LID. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222975 ↗
• MalfunctionJun 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE FIELD SERVICE ENGINEER (FSE) REPORTED TO OLYMPUS, THE WASHING CASE WAS BEING USED OFF LABEL. FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER'S FACILITY AND NOTICED THAT THE WASHING BASIN LIDS WERE REMOVED FROM THE WASHING BASIN CUP, FSE REATTACHED 3 OUT OF 4 WASHING BASIN LIDS AND THE CUSTOMER COULD NOT FIND THE 4TH LID AND WILL BE LOOKING FOR THE LID. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222921 ↗
• MalfunctionJun 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE FIELD SERVICE ENGINEER (FSE) REPORTED TO OLYMPUS, THE WASHING CASE WAS BEING USED OFF LABEL. THE LIDS OF THE WASHING BASIN WERE REMOVED FROM THE WASHING BASIN CUP AND ONLY THREE OF THE FOUR LIDS COULD BE FOUND. IT WAS REPORTED THAT WHEN REPROCESSING A SINGLE DILATOR WITH A SCOPE, THE DILATOR WAS CONNECTED BY THE ORANGE CONNECTOR D2 WITH A LURE LOCK NEEDLE ATTACHED TO THE D2 CONNECTOR. THIS CONNECTOR IS USED TO REPROCESS THE MAJ-855 TUBING AND THE AUX CHANNEL OF THE SCOPE. IT WAS ALSO NOTED THAT THE MAJ-855 TUBING WAS FREELY IN THE BASIN WITH NO CONNECTION TO HIGH LEVEL DISINFECT. THERE WAS ALSO CONNECTORS A1, B1, C1, D1 TWO SETS FREELY BEING REPROCESSED AT THAT TIME. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE FSE STOPPED THE CYCLE AND EDUCATED THE STAFF AND CHANGE NURSE, ADVISING THAT OLYMPUS DOES NOT VALIDATE DILATORS OR FREELY PLACED ITEMS IN THE OER-ELITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222603 ↗
• MalfunctionJun 28, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE FIELD SERVICE ENGINEER (FSE) REPORTED TO OLYMPUS, THE WASHING CASE WAS BEING USED OFF LABEL. THE LIDS OF THE WASHING BASIN WERE REMOVED FROM THE WASHING BASIN CUP AND ONLY THREE OF THE FOUR LIDS COULD BE FOUND. IT WAS REPORTED THAT WHEN REPROCESSING A SINGLE DILATOR WITH A SCOPE, THE DILATOR WAS CONNECTED BY THE ORANGE CONNECTOR D2 WITH A LURE LOCK NEEDLE ATTACHED TO THE D2 CONNECTOR. THIS CONNECTOR IS USED TO REPROCESS THE MAJ-855 TUBING AND THE AUX CHANNEL OF THE SCOPE. IT WAS ALSO NOTED THAT THE MAJ-855 TUBING WAS FREELY IN THE BASIN WITH NO CONNECTION TO HIGH LEVEL DISINFECT. THERE WAS ALSO CONNECTORS A1, B1, C1, D1 TWO SETS FREELY BEING REPROCESSED AT THAT TIME. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE FSE STOPPED THE CYCLE AND EDUCATED THE STAFF AND CHANGE NURSE, ADVISING THAT OLYMPUS DOES NOT VALIDATE DILATORS OR FREELY PLACED ITEMS IN THE OER-ELITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190969. One submission often covers many models, so check the product and lot details in each record.

• Z-0638-2022 · Dec 13, 2021 · Terminated
  OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessor