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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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