Suction cleaning adapter MH-856 (UDI 04953170071270)Recalls & reported problems
Olympus Medical Systems Corp. · "MH-856 SUCTION CLEANING ADPTER -OES/EVIS" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170071270), received between Jun 12, 2021 and Nov 6, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (7 reports).
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.
Reports received per month
Most reported problems
Device problems
- Device Reprocessing Problem7
- Failure to Disinfect1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REQUESTED AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST CONDUCT A REPROCESSING IN-SERVICE. WHILE ONSITE, IT WAS DISCOVERED THE CUSTOMER WAS NOT REPROCESSING THE AUXILIARY WATER TUBE, SUCTION CLEANING ADAPTER, AND INJECTION TUBE AFTER EACH USE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18080948 ↗MalfunctionNov 22, 2022Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER DID NOT KNOW THE TUBING THAT WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15845580 ↗MalfunctionOct 13, 2021Device Reprocessing Problem; Device Reprocessing Problem
OVER A THREE-DAY TIMEFRAME, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO OBSERVE THE REPROCESSING METHODS PERFORMED ON THE OLYMPUS SCOPES IN-HOUSE. DURING THIS ONSITE VISIT, THE SUCTION CLEANING ADAPTER USED IN THE CLEANING OF SCOPES WAS FOUND TO BE INCORRECTLY CLEANED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS EVENT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12627760 ↗MalfunctionOct 13, 2021Device Reprocessing Problem; Device Reprocessing Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. ACCORDING TO THE USER FACILITY, AFTER THE FINAL REPORT IS PROVIDED BY OLYMPUS, THIS EVENT WILL BE ADDRESSED WITH PERSONNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12623772 ↗MalfunctionOct 13, 2021Device Reprocessing Problem; Device Reprocessing Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. ACCORDING TO THE USER FACILITY, AFTER THE FINAL REPORT IS PROVIDED BY OLYMPUS, THIS EVENT WILL BE ADDRESSED WITH PERSONNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12623763 ↗MalfunctionOct 11, 2021Device Reprocessing Problem; Device Reprocessing Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. ACCORDING TO THE USER FACILITY, AFTER THE FINAL REPORT IS PROVIDED BY OLYMPUS, THIS EVENT WILL BE ADDRESSED WITH PERSONNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605967 ↗MalfunctionAug 9, 2021Failure to Disinfect; Failure to Disinfect
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE WAS CLEANED BUT NOT STERILIZED BEFORE BEING USED WITH ANOTHER SCOPE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12294050 ↗MalfunctionJun 12, 2021Device Reprocessing Problem; Device Reprocessing Problem
THE SERVICE CENTER WAS INFORMED THAT THE CUSTOMER NEEDED CLARIFICATION ON THE CLEANING PROCESS OF THE SUCTION CLEANING ADAPTER. THE CUSTOMER WAS USING AN ALCOHOL FLUSH TO CLEAN IT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11988571 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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