EVIS DUODENOVIDEOSCOPERecalls & reported problems across all models

We found 3 models of EVIS DUODENOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2018 and Jul 17, 2026 — classified as 11 injuries, 15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EVIS DUODENOVIDEOSCOPE problems

EVIS DUODENOVIDEOSCOPE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EVIS DUODENOVIDEOSCOPE JF-140R

  duodenoscope and accessories, flexible/rigid
  12 reports
• EVIS DUODENOVIDEOSCOPE OLYMPUS JF TYPE 140F

  Endoscopic video imaging system/component, gastroenterology-urology
  10 reports
• EVIS DUODENOVIDEOSCOPE OLYMPUS JF TYPE 140F

  Endoscopic video imaging system/component, gastroenterology-urology
  4 reports

Recent EVIS DUODENOVIDEOSCOPE adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "RISK FACTORS FOR POST-ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PANCREATITIS IN CHILDREN WITH CHRONIC PANCREATITIS AND ITS PREDICTION USING 4-HOUR POSTPROCEDURE SERUM AMYLASE AND LIPASE LEVELS". THIRTY CHILDREN WITH CHRONIC PANCREATITIS (CP) WHO UNDERWENT 62 ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) PROCEDURES WERE STUDIED. POST¿ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PANCREATITIS (PEP) OCCURRED IN 14.5% (9/62) OF ERCP PROCEDURES (MILD: 8, MODERATE:1) WITH NO MORTALITY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PEP: 9/62 {PANCREATIC PSEUDOCYST -1, EPIGASTRIC PAIN ABDOMEN -9, NONBILIOUS VOMITING -5, BULKY PANCREAS -6} 8 MILD, 1 MODERATELY SEVERE. SYMPTOMS (ABDOMINAL PAIN, NAUSEA, AND VOMITING) AND SIGNS (ABDOMINAL TENDERNESS) OF PANCREATITIS WERE CLINICALLY EVALUATED FOR 24 HOURS AFTER ERCP. IF THE CHILD DEVELOPED ABDOMINAL PAIN ANY TIME AFTER THE PROCEDURE THEY WERE EVALUATED FOR CAUSE OF PAIN AND STARTED ON SYMPTOMATIC TREATMENT (NOTHING BY MOUTH, INTRAVENOUS FLUIDS, AND ANALGESICS). THE DIAGNOSIS OF PEP WAS BASED ON NEW OR WORSENED ABDOMINAL PAIN COMBINED WITH ELEVATED SERUM PANCREATIC E

  Patient problems: Abdominal Pain; Cyst(s); Nausea; Pancreatitis; Vomiting

  MAUDE report 19514969 ↗
• MalfunctionMay 29, 2024Degraded; Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WIRE OF THE FORCEPS ELEVATOR SYSTEM OF THE DUEODENOVIDEOSCOPE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19419954 ↗
• 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 ↗
• MalfunctionMar 9, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE CLAMP WAS ABNORMAL, AND THE LOWER ATTACHMENT DOES NOT GO DOWN INSIDE THE PATIENT [FORCEPS CANNOT BE INSERTED OR REMOVED]. THERE WAS NO PATIENT OR USER INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515490 ↗
• MalfunctionJan 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE DISTAL END CAP HAD A CUT. THE CUSTOMER CONFIRMED THAT THERE WAS A CRACK FOUND ON THE CAP DURING REPROCESSING. THERE WAS NO TISSUE, BLOOD OR ANYTHING FROM THE PATIENT¿S BODY WAS FOUND ON THE CRACKED DISTAL END CAP BEFORE OR DURING REPROCESSING. AFTER REPROCESSING, THE DEVICE WAS ONLY WASHED. DURING INSPECTION AND TESTING OF THE RETURNED DEVICE, THE FORCEPS ELEVATOR WAS FOUND TO HAVE FOREIGN MATERIAL, WHICH HAS BEEN ATTRIBUTED TO INADEQUATE CLEANING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16212392 ↗
• 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 ↗
• MalfunctionDec 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER SENT THE SUBJECT DEVICE TO AN OLYMPUS SERVICE CENTER FOR EVALUATION WITH A REPORT THAT THE FORCEPS COULD NOT BE INSERTED OR REMOVED. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925359 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOSCOPIC ULTRASOUND-DIRECTED TRANSGASTRIC ERCP (EDGE): A RETROSPECTIVE MULTICENTER STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DUODENOSCOPES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE TJF-Q180V USED IN THE EDGE PROCEDURES CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE "SLIM" DUODENOSCOPE USED IN THE EDGE PROCEDURES (EITHER JF-Q140V, JF-Q160V, OR JF-Q180V). BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND-DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP; EDGE) IS AN ALTERNATIVE TO ENTEROSCOPY- AND LAPAROSCOPY-ASSISTED ERCP IN PATIENTS WITH ROUX-EN-Y GASTRIC BYPASS ANATOMY. ALTHOUGH SHORT-TERM RESULTS ARE PROMISING, THE LONG-TERM OUTCOMES ARE NOT KNOWN. THE AIMS OF THIS STUDY WERE: (1) TO DETERMINE THE RATES OF LONG-TERM ADVERSE EVENTS AFTER EDGE, WITH A FOCUS ON RATES OF PERSISTENT GASTROGASTRIC OR JEJUNOGASTRIC FISTULA; (2) TO IDENTIFY PREDICTORS OF PERSISTENT FISTULA; (3) TO ASSESS THE OUTCOMES OF ENDOSCOPIC CLOSURE WHEN PERSISTENT FISTULA IS ENCOUNTERED. METHOD: MULTICENTER RETROSPECTIVE STUDY INVOLVING 13 CENTERS BETWEEN FEBRUARY 2015 AND MARCH 2019. ADVERSE EVENTS WERE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Unspecified Hepatic or Biliary Problem

  MAUDE report 14021318 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOSCOPIC ULTRASOUND-DIRECTED TRANSGASTRIC ERCP (EDGE): A RETROSPECTIVE MULTICENTER STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DUODENOSCOPES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE TJF-Q180V USED IN THE EDGE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE "SLIM" DUODENOSCOPE USED IN THE EDGE PROCEDURES (EITHER JF-Q140V, JF-Q160V, OR JF-Q180V). BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND-DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP; EDGE) IS AN ALTERNATIVE TO ENTEROSCOPY- AND LAPAROSCOPY-ASSISTED ERCP IN PATIENTS WITH ROUX-EN-Y GASTRIC BYPASS ANATOMY. ALTHOUGH SHORT-TERM RESULTS ARE PROMISING, THE LONG-TERM OUTCOMES ARE NOT KNOWN. THE AIMS OF THIS STUDY WERE: (1) TO DETERMINE THE RATES OF LONG-TERM ADVERSE EVENTS AFTER EDGE, WITH A FOCUS ON RATES OF PERSISTENT GASTROGASTRIC OR JEJUNOGASTRIC FISTULA; (2) TO IDENTIFY PREDICTORS OF PERSISTENT FISTULA; (3) TO ASSESS THE OUTCOMES OF ENDOSCOPIC CLOSURE WHEN PERSISTENT FISTULA IS ENCOUNTERED METHOD: MULTICENTER RETROSPECTIVE STUDY INVOLVING 13 CENTERS BETWEEN FEBRUARY 2015 AND MARCH 2019. ADVERSE EVENTS WERE

  Patient problems: Fistula

  MAUDE report 14021312 ↗
• MalfunctionJan 26, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION FOR USE, THE ELEVATOR WIRE WAS CUT OFF. THE DEVICE WAS RETURNED FOR REPAIR AND THE FORCEPS ELEVATOR WAS FOUND TO HAVE FOREIGN MATERIAL AND THE INSIDE OF THE LIGHT GUIDE LENS WAS DIRTY. THESE ARE REPORTABLE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357303 ↗
• MalfunctionNov 9, 2021Microbial Contamination of Device; Microbial Contamination of Device

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE RESULTS OF TWO CULTURE TESTS PERFORMED FOR THE DEVICE WERE POSITIVE FOR GERMS. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781145 ↗
• 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 ↗
• MalfunctionApr 13, 2021Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS RECEIVED THE FOLLOWING ARTICLE ON (B)(6) 2021 FROM THE US/EMEA MEDTECH NEWSLETTER: (B)(6) 2021 (9934 GASTROINTESTINAL ENDOSCOPY VOLUME 93, NO. 4: 2021): ENHANCED REPROCESSING OF DUODENOSCOPES: A GLASS HALF FULL OR HALF EMPTY? GASTROINTESTINAL ENDOSCOPY SUSHRUT SUJAN THIRUVENGADAM, MD V. RAMAN MUTHUSAMY, MD, MAS- (B)(6) 2021. THE AIM OF THIS STUDY WAS TO COMPARE THE EFFICACY OF REPROCESSING DUODENOSCOPES WITH EITHER DOUBLE HIGH-LEVEL DISINFECTION (DHLD) OR LIQUID CHEMICAL STERILIZATION (LCS). THIS WAS A PROSPECTIVE RANDOMIZED STUDY USING 67 DUODENOSCOPES (OLYMPUS MODELS TJF-Q180 (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)) AND TJF-160 (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)) RANDOMIZED, AND 10 OLDER-MODEL DUODENOSCOPES, OLYMPUS JF-130 (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)), JF-140 (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)), AND TJF-140 (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)) WHICH WERE INCLUDED IN THIS ANALYSIS BUT WERE NOT RANDOMIZED. ALL OLDER SCOPES WERE REPROCESSED WITH DHLD, GIVEN THE INSTITUTIONAL EXPERIENCE WITH DHLD ON THESE LESS COMMONLY USED MODELS. DUODENOSCOPES WERE RANDOMLY CULTURED AFTER REPROCESSING. THERE WAS NO PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655250 ↗
• 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 ↗

Other Olympus Medical Systems Corp. products

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• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports