EVIS EXERA DUODENOVIDEOSCOPE OLYMPUS PJF TYPE 160Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170433498), received between Aug 9, 2021 and Oct 23, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, THE DUODENOVIDEOSCOPE¿S FORCEPS ELEVATOR DOES NOT MOVE DOWN AT ALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514144 ↗
• MalfunctionJul 17, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED THE DUODENOSCOPE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334109 ↗
• InjuryMay 4, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING THIS DUODENOVIDEOSCOPE, THE ELEVATOR WAS ALMOST IMPOSSIBLE TO USE FROM THE BEGINNING OF THE CASE. IT FELT LIKE IT WAS GRINDING AT THE DIALS AND DID NOT LOOSEN UP WITH A COUPLE OF DROPS OF MINERAL OIL. THE USER HAD TO USE TWO HANDS TO MANIPULATE THE ELEVATOR. IT MADE IT VERY DIFFICULT AND PROLONGED CASE. THE PROCEDURE WAS PROLONGED FOR ONE HOUR. MULTIPLE INADVERTENT PANCREATIC DUCT CANNULATION MAY HAVE OCCURRED AS A RESULT OF THE ISSUE, AS REPORTED BY THE PHYSICIAN. THE PATIENT HAD VERY HIGH LIPASE POST PROCEDURE WITH BRIEF PERIOD OF SELF-RESOLVED PAIN. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED PROBLEM. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. OLYMPUS WAS FURTHER INFORMED THAT THE PATIENT IS LESS THAN 1 YEAR OLD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16874013 ↗
• InjuryMay 4, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING THIS DUODENOVIDEOSCOPE, THE ELEVATOR WAS ALMOST IMPOSSIBLE TO USE FROM THE BEGINNING OF THE CASE. IT FELT LIKE IT WAS GRINDING AT THE DIALS AND DID NOT LOOSEN UP WITH A COUPLE OF DROPS OF MINERAL OIL. THE USER HAD TO USE TWO HANDS TO MANIPULATE THE ELEVATOR. IT MADE IT VERY DIFFICULT AND PROLONGED CASE. THE PROCEDURE WAS PROLONGED FOR ONE HOUR. MULTIPLE INADVERTENT PANCREATIC DUCT CANNULATION MAY HAVE OCCURRED AS A RESULT OF THE ISSUE, AS REPORTED BY THE PHYSICIAN. THE PATIENT HAD VERY HIGH LIPASE POST PROCEDURE WITH BRIEF PERIOD OF SELF-RESOLVED PAIN. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED PROBLEM. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. OLYMPUS WAS FURTHER INFORMED THAT THE PATIENT IS LESS THAN 1 YEAR OLD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 16873828 ↗
• MalfunctionApr 27, 2022Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS RECEIVED AN ARTICLE, WHICH WAS TITLED: ¿"ASSESSMENT OF POST-MANUAL CLEANING ADENOSINE TRIPHOSPHATE TESTS TO PREVENT THE USE OF CONTAMINATED DUODENOSCOPES AND LINEAR ECHOENDOSCOPES: THE DETECT STUDY." METHODS: IN THIS SINGLE-CENTER BEFORE-AND-AFTER STUDY, DLES WERE ATP TESTED POST-CLEANING. DURING THE CONTROL PERIOD PARTICIPANTS WERE BLINDED FOR ATP RESULTS: ATP-POSITIVE DLES WERE NOT RECLEANED. DURING THE INTERVENTION PERIOD ATP-POSITIVE DLES WERE RECLEANED. DLES UNDERWENT MICROBIOLOGICAL SAMPLING AFTER HIGH LEVEL DISINFECTION (HLD) WITH PARTICIPANTS BLINDED FOR CULTURE RESULTS. RESULTS: USING FIFTEEN ENDOSCOPES OF FIVE DIFFERENT DLE TYPES, NINE-HUNDRED-NINE PROCEDURES WERE INCLUDED (52% DUODENOSCOPES, 48% LINEAR ECHOENDOSCOPES). DURING THE INTERVENTION PERIOD THE ABSOLUTE RATE OF CONTAMINATION WITH GUT FLORA WAS HIGHER (16% VS 21%). MAIN ANALYSIS SHOWED THAT CONTAMINATION WAS LESS LIKELY TO OCCUR IN THE INTERVENTION PERIOD (OR 0.32; 95%CI 0.12-0.85). SECONDARY ANALYSIS SHOWED THAT THIS EFFECT WAS BASED ON ONE PARTICULAR DUODENOSCOPE TYPE (ESTIMATED PROBABILITY 39%; 95%CI 18%-64% VS 9%; 95%CI 2%-21%), WHILE NO EFFECT WAS SEEN IN THE OTHER FOUR DLE TYPES. IN DETAIL, OF THE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220316 ↗
• MalfunctionApr 27, 2022Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS RECEIVED AN ARTICLE, WHICH WAS TITLED: ¿"ASSESSMENT OF POST-MANUAL CLEANING ADENOSINE TRIPHOSPHATE TESTS TO PREVENT THE USE OF CONTAMINATED DUODENOSCOPES AND LINEAR ECHOENDOSCOPES: THE DETECT STUDY." METHODS: IN THIS SINGLE-CENTER BEFORE-AND-AFTER STUDY, DLES WERE ATP TESTED POST-CLEANING. DURING THE CONTROL PERIOD PARTICIPANTS WERE BLINDED FOR ATP RESULTS: ATP-POSITIVE DLES WERE NOT RECLEANED. DURING THE INTERVENTION PERIOD ATP-POSITIVE DLES WERE RECLEANED. DLES UNDERWENT MICROBIOLOGICAL SAMPLING AFTER HIGH LEVEL DISINFECTION (HLD) WITH PARTICIPANTS BLINDED FOR CULTURE RESULTS. RESULTS: USING FIFTEEN ENDOSCOPES OF FIVE DIFFERENT DLE TYPES, NINE-HUNDRED-NINE PROCEDURES WERE INCLUDED (52% DUODENOSCOPES, 48% LINEAR ECHOENDOSCOPES). DURING THE INTERVENTION PERIOD THE ABSOLUTE RATE OF CONTAMINATION WITH GUT FLORA WAS HIGHER (16% VS 21%). MAIN ANALYSIS SHOWED THAT CONTAMINATION WAS LESS LIKELY TO OCCUR IN THE INTERVENTION PERIOD (OR 0.32; 95%CI 0.12-0.85). SECONDARY ANALYSIS SHOWED THAT THIS EFFECT WAS BASED ON ONE PARTICULAR DUODENOSCOPE TYPE (ESTIMATED PROBABILITY 39%; 95%CI 18%-64% VS 9%; 95%CI 2%-21%), WHILE NO EFFECT WAS SEEN IN THE OTHER FOUR DLE TYPES. IN DETAIL, OF THE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220310 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CONJUGATED HYPERBILIRUBINEMIA IN INFANTS: IS THERE STILL A ROLE FOR ERCP?". THE LITERATURE REPORTED THE RESULT OF 255 PATIENTS (INFANTS AGED UP TO 1 YEAR) WITH SUSPICION OF BILIARY OBSTRUCTION WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING OLYMPUS PEDIATRIC DUODENOSCOPE PJF AND ANOTHER DEVICE. IN THE LITERATURE, THE FOLLOWING COMPLICATIONS HAVE BEEN REPORTED TO HAVE OCCURRED. ASYMPTOMATIC HYPERAMYLASEMIA (12.9%). SUSPICION OF PERFORATION (1 CASE). RETROPERITONEAL DEPOT OF THE CONTRAST MEDIUM (1 CASE). THE LITERATURE STATES AS FOLLOWS, "THE OVERALL COMPLICATION RATE WAS 13.7% OF ERCP PROCEDURES. ASYMPTOMATIC HYPERAMYLASEMIA OCCURRED IN 12.9%. IT IS QUESTIONABLE IF ASYMPTOMATIC HYPERAMYLASEMIA SHOULD BE INCLUDED IN THE COMPLICATION RATE. THE SUSPICION OF PERFORATION (ABDOMINAL PAIN AND ELEVATION OF CRP) OCCURRED IN ONE CHOLESTATIC INFANT WITH A CHOLEDOCHAL CYST AFTER AN UNSUCCESSFUL BILIARY STENT INSERTION. THE PROBLEM WAS RESOLVED CONSERVATIVELY WITH PARENTERAL NUTRITION AND INTRAVENOUS ANTIBIOTIC THERAPY. IN ONE CASE, A RETROPERITONEAL DEPOT OF THE CONTRAST MEDIUM EMERGED DURING

  Patient problems: Perforation

  MAUDE report 13331537 ↗
• MalfunctionAug 9, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT IS REPORTED IN THE LITERATURE TITLED "ENDOSCOPIC TRANSMISSION OF CARBAPENEM-RESISTANT ENTEROBACTERIACEAE: IMPLICATIONS FOR FOOD AND DRUG ADMINISTRATION APPROVAL AND POSTMARKET SURVEILLANCE OF ENDOSCOPIC DEVICES", OLYMPUS SCOPES HAD POSITIVE CULTURES AFTER REPROCESSING. THE STUDY PRESENTED AN OVERVIEW OF THE FDA APPROVAL OF DUODENOSCOPES BY ANALYZING FDA¿S 510(K) PREMARKET NOTIFICATION DATABASE FOR DATA SUPPORTING CLEARANCE OF DUODENOSCOPE MODELS IMPLICATED IN CARBAPENEM-RESISTANT ENTEROCOCCUS (CRE)-RELATED OUTBREAKS, AS WELL AS SUBSEQUENTLY REQUIRED POSTMARKET STUDIES. THE STUDY ADDRESSED THE POLICY IMPLICATIONS OF CRE OUTBREAKS ON POSTMARKETING SURVEILLANCE AND THE NEED FOR INCREASED GASTROENTEROLOGIST INVOLVEMENT IN THE LIFECYCLE OF DUODENOSCOPES AND OTHER MEDICAL DEVICES. THE STUDY INCLUDED REPORTING THOROUGH ADVERSE EVENT DATA TO FDA AND DEVICE MANUFACTURERS, AS WELL AS SUPPORTING ACTIVE SURVEILLANCE STUDIES TO ENSURE SAFETY AND EFFECTIVENESS AND EVALUATING IMPLEMENTATION OF RECOMMENDATIONS TO REDUCE ADVERSE EVENTS. AN ONGOING SAMPLING AND CULTURING STUDY INVOLVING OLYMPUS PJF-160, JF-140F, TJF-160F, TJF-160VF, AND TJF-Q180V SCOPES WAS REFERENCED. THE PRELIMINARY DATA SHOWED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12296971 ↗