EVIS DUODENOVIDEOSCOPE OLYMPUS JF TYPE 140F (UDI 04953170066344)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170066344), received between Dec 7, 2018 and May 3, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BEEN REPROCESSED WITH AN ENDOSCOPE REPROCESSOR IN WHICH THE WATER FILTER REPLACEMENT DEADLINE HAD EXPIRED BY TWO YEARS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237934 ↗
• MalfunctionJan 10, 2023Crack; Crack

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS DUODENOVIDEOSCOPE PLASTIC DISTAL END COVER WAS CRACKED. ALTHOUGH REQUESTED, THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER DETAILS. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128717 ↗
• MalfunctionJul 11, 2019Microbial Contamination of Device; Microbial Contamination of Device

  THE MANUFACTURE WAS INFORMED THAT DURING A POST MARKET STUDY THE SCOPE CULTURED POSITIVE FOR KLEBSIELLA PNEUMONIAE AFTER REPROCESSING. THERE WAS NO ASSOCIATED PATIENT INFECTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781821 ↗
• MalfunctionDec 7, 2018Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS WAS INFORMED THAT DURING A POST MARKET SURVEILLANCE STUDY THE SCOPE CULTURED POSITIVE FOR A HIGH CONCERN MICROORGANISM, ESCHERICHIA COLI / SHIGELLA DYSENTERIAE, AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED AN IN-SERVICE ON REPROCESSING WAS LAST PERFORMED BY AT THE USER FACILITY ON NOVEMBER 2, 2018 AND ON NOVEMBER 5, 2018. ALL REPROCESSING PERSONNEL WERE PROPERLY TRAINED. HOWEVER, THE TECHNICIAN WHO REPROCESSED THIS SCOPE HAS NOT BEEN IN-SERVICED BY OLYMPUS AND WAS TRAINED BY THEIR STAFF. THE STAFF IS FOLLOWING THE INSTRUCTION MANUAL'S REPROCESSING RECOMMENDATIONS. IN ADDITION, PRE-CLEANING IS BEING PERFORMED IMMEDIATELY AFTER A PROCEDURE. THE ENDOSCOPE IS BEING LEAK TESTED PRIOR TO MANUAL CLEANING. THE ENDOSCOPE CHANNEL IS BRUSHED DURING MANUAL CLEANING. THE MINIMUM EFFECTIVE CONCENTRATION IS CHECKED BEFORE EVERY SCOPE. THE NON-OLYMPUS AER HAS NO REPORTED ISSUES AND IT IS UNKNOWN WHEN THE LAST MAINTENANCE WAS PERFORMED. THE SCOPE IS STORED IN A STORAGE CABINET, HANGING VERTICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143228 ↗