EVIS DUODENOVIDEOSCOPE JF-140RRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170339851), received between Jul 23, 2019 and Jun 11, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 19, 2020Break; Break

  SOME OF THE WIRES THAT COMPOSES THE FORCEPS ELEVATOR WIRE OF THE SUBJECT DEVICE WERE CUT AND RAISED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069196 ↗
• MalfunctionJul 23, 2019Break; Break

  OLYMPUS SERVICE DEPARTMENT FOUND THAT THE FORCEPS ELEVATOR WAS PARTIALLY DETACHED FROM THE SUBJECT DEVICE. OTHER DETAILED INFORMATION WAS NOT PROVIDED SUCH AS WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815036 ↗