EVIS DUODENOVIDEOSCOPE OLYMPUS JF TYPE 140F (UDI 04953170339844)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170339844), received between May 19, 2020 and Jul 17, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Crack; Peeled/Delaminated

  THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIP, CRACK, PEELING ON CEMENT ON OB LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25858451 ↗
• MalfunctionMay 5, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "RESIDUAL MOISTURE AND WATERBORNE PATHOGENS INSIDE FLEXIBLE ENDOSCOPES: EVIDENCE FROM A MULTISITE STUDY OF ENDOSCOPE DRYING EFFECTIVENESS," 22 DIFFERENT MODEL SCOPES TESTED POSITIVE FOR MICROORGANISMS AFTER REPROCESSING. BACKGROUND: ENDOSCOPY-ASSOCIATED INFECTION TRANSMISSION IS FREQUENTLY LINKED TO INADEQUATE REPROCESSING. RESIDUAL ORGANIC MATERIAL AND MOISTURE MAY FOSTER BIOFILM DEVELOPMENT INSIDE ENDOSCOPES. THIS STUDY EVALUATED THE EFFECTIVENESS OF ENDOSCOPE DRYING AND STORAGE METHODS AND ASSESSED ASSOCIATIONS BETWEEN RETAINED MOISTURE AND CONTAMINATION. METHODS: ENDOSCOPE REPROCESSING, DRYING, AND STORAGE PRACTICES WERE ASSESSED AT 3 HOSPITALS. RESEARCHERS PERFORMED VISUAL EXAMINATIONS AND TESTS TO DETECT FLUID AND CONTAMINATION ON PATIENT-READY ENDOSCOPES. RESULTS: FLUID WAS DETECTED IN 22 OF 45 (49%) ENDOSCOPES. PREVALENCE OF MOISTURE VARIED SIGNIFICANTLY BY SITE (5%; 83%; 85%; P < .001). HIGH ADENOSINE TRIPHOSPHATE LEVELS WERE FOUND IN 22% OF ENDOSCOPES, AND MICROBIAL GROWTH WAS DETECTED IN 71% OF ENDOSCOPES. STENOTROPHOMONAS MALTOPHILIA, CITROBACTER FREUNDII, AND LECANICILLIUM LECANII/VERTICILLIUM DAHLIAE WERE FOUND. RETAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776025 ↗
• InjuryMay 20, 2020Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem; Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A REPORT FROM A USER FACILITY, STATING TWO PATIENTS HAD DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES 2 DAYS APART THAT USED THE SAME SCOPE. PATIENT 1 HAD AN ERCP (B)(6) 2020 AND PATIENT 2, HAD AN ERCP ON (B)(6) 2020. THE SCOPE WAS NOT USED ON ANY OTHER PATIENT IN BETWEEN THESE TWO PATIENTS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER FACILITY REGARDING THE TREATMENT OF THE INFECTIONS IN EITHER PATIENT. THIS REPORT IS FOR PATIENT 1.

  Patient problems: Bacterial Infection

  MAUDE report 10075460 ↗
• InjuryMay 20, 2020Microbial Contamination of Device

  OLYMPUS RECEIVED A REPORT FROM A USER FACILITY, STATING TWO PATIENTS HAD DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES 2 DAYS APART THAT USED THE SAME SCOPE. PATIENT 1 HAD AN ERCP (B)(6) 2020 AND PATIENT 2, HAD AN ERCP ON (B)(6) 2020. THE SCOPE WAS NOT USED ON ANY OTHER PATIENT IN BETWEEN THESE TWO PATIENTS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER FACILITY REGARDING THE TREATMENT OF THE INFECTIONS IN EITHER PATIENT. A REVIEW OF THE SERVICE HISTORY INDICATES THE SCOPE WAS PURCHASED ON (B)(6) 1998 AND HAS RECEIVED TWO SERVICES IN THE LAST YEAR. THESE REPAIRS WERE NOT RELATED TO ANY POSITIVE PATIENT OR SCOPE C

  Patient problems: Bacterial Infection

  MAUDE report 10075383 ↗
• InjuryMay 19, 2020Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem; Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A REPORT FROM A USER FACILITY, STATING TWO PATIENTS HAD DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES 2 DAYS APART THAT USED THE SAME SCOPE. PATIENT 1 HAD AN ERCP(B)(6) 2020 AND PATIENT 2, HAD AN ERCP ON (B)(6) 2020. THE SCOPE WAS NOT USED ON ANY OTHER PATIENT IN BETWEEN THESE TWO PATIENTS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER FACILITY REGARDING THE TREATMENT OF THE INFECTIONS IN EITHER PATIENT. THIS REPORT CAPTURES PATIENT 2.

  Patient problems: Bacterial Infection

  MAUDE report 10072982 ↗
• InjuryMay 19, 2020Improper or Incorrect Procedure or Method; Microbial Contamination of Device

  OLYMPUS RECEIVED A REPORT FROM A USER FACILITY, STATING TWO PATIENTS HAD DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES 2 DAYS APART THAT USED THE SAME SCOPE. PATIENT 1 HAD AN ERCP (B)(6) 2020 AND PATIENT 2, HAD AN ERCP ON (B)(6) 2020. THE SCOPE WAS NOT USED ON ANY OTHER PATIENT IN BETWEEN THESE TWO PATIENTS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER FACILITY REGARDING THE TREATMENT OF THE INFECTIONS IN EITHER PATIENT. A REVIEW OF THE SERVICE HISTORY INDICATES THE SCOPE WAS PURCHASED ON (B)(6) 1998 AND HAS RECEIVED TWO SERVICES IN THE LAST YEAR. THESE REPAIRS WERE NOT RELATED TO ANY POSITIVE PATIENT OR SCOPE C

  Patient problems: Bacterial Infection

  MAUDE report 10072814 ↗
• InjuryMay 19, 2020Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem; Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A COMPLAINT FROM A USER FACILITY STATING THAT THERE WAS CONCERN ABOUT TWO PATIENTS THAT DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). PATIENT 2 HAD AN ERCP, THE PATIENT WAS NOT KNOWN TO HAVE CRE PRIOR TO THE ERCP. ON (B)(6) 2020 PATIENT 2 HAD AN ERCP WITH JF-140F, SN (B)(4). THIS PARTICULAR SCOPE WAS USED ON 3 ADDITIONAL PATIENTS WITHOUT ANY EVIDENCE OF TRANSMISSION. ON (B)(6) 2020, PATIENT 2 HAD A URINE CULTURE WHICH WAS POSITIVE FOR CRE. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. PATIENT 2 WAS AN INPATIENT ON THE SAME UNIT WHERE ANOTHER PATIENT TESTED POSITIVE FOR CRE AND SHARED CAREGIVERS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER FACILITY R

  Patient problems: Bacterial Infection

  MAUDE report 10072318 ↗
• InjuryMay 19, 2020Microbial Contamination of Device

  OLYMPUS RECEIVED A COMPLAINT FROM A USER FACILITY STATING THAT THERE WAS CONCERN ABOUT TWO PATIENTS THAT DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). PATIENT 2 HAD AN ERCP, THE PATIENT WAS NOT KNOWN TO HAVE CRE PRIOR TO THE ERCP. ON 1/30/2020 PATIENT 2 HAD AN ERCP WITH JF-140F, SN (B)(4). THIS PARTICULAR SCOPE WAS USED ON 3 ADDITIONAL PATIENTS WITHOUT ANY EVIDENCE OF TRANSMISSION. ON (B)(6) 2020, PATIENT 2 HAD A URINE CULTURE WHICH WAS POSITIVE FOR CRE. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. PATIENT 2 WAS AN INPATIENT ON THE SAME UNIT WHERE ANOTHER PATIENT TESTED POSITIVE FOR CRE AND SHARED CAREGIVERS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER FACILITY REG

  Patient problems: Bacterial Infection

  MAUDE report 10071671 ↗
• InjuryMay 19, 2020Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem; Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A COMPLAINT FROM A USER FACILITY STATING THAT THERE WAS CONCERN ABOUT TWO PATIENTS THAT DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). PATIENT 1 HAD AN ERCP, THE PATIENTS WERE NOT KNOWN TO HAVE CRE PRIOR TO THE ERCPS. ON (B)(6) 2020 PATIENT 1 HAD AN ERCP WITH JF-140F, SN (B)(4). THIS PARTICULAR SCOPE WAS USED ON 3 ADDITIONAL PATIENTS WITHOUT ANY EVIDENCE OF TRANSMISSION. ON (B)(6) 2020, PATIENT 1 HAD BLOOD CULTURES DRAWN WHICH WERE POSITIVE FOR CRE. THE SCOPE WAS DOUBLE MANUALLY CLEANED AND DOUBLE HIGH-LEVEL DISINFECTED BETWEEN PATIENTS AS IS THEIR USUAL PROCESS. PATIENT 1 WAS AN INPATIENT ON THE SAME UNIT WHERE ANOTHER PATIENT TESTED POSITIVE FOR CRE AND SHARED CAREGIVERS. BOTH ISOLATES WERE SENT FOR GENOMIC ANALYSIS AND HAVE MATCHING CHROMOSOMAL PATTERNS. THE USER FACILITY SUSPECTS THAT TRANSMISSION OCCURRED EITHER VIA DUODENOSCOPE OR THROUGH SHARED CAREGIVERS. ALL THE 140 SERIES SCOPES WERE SENT THROUGH ETO STERILIZATION, PER FACILITY PROTOCOL, AND WERE NOT CULTURED PRIOR. THE JF-140F SCOPE HAS BEEN QUARANTINED AT THE USER FACILITY. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE USER F

  Patient problems: Bacterial Infection

  MAUDE report 10071542 ↗
• InjuryMay 19, 2020Microbial Contamination of Device

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT SECTION G6; 5-DAY REPORT SELECTED IN ERROR. G6: TYPE OF REPORT ¿ INITIAL (30-DAY).

  Patient problems: Bacterial Infection

  MAUDE report 10071424 ↗