EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180J (UDI 04953170275456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 04953170275456), received between Aug 5, 2020 and Sep 18, 2024 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (21 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER SUPPLY AND NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247047 ↗
• MalfunctionSep 6, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE HAD CLOGGED AUXILIARY CHANNEL DUE TO FOREIGN MATERIAL INSIDE THE CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162891 ↗
• MalfunctionJun 5, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE GASTROINTESTINAL TESTED POSITIVE FOR AN UNSPECIFIED QUANTITY OF BACTERIA PSEUDOMONAS AERUGINOSA. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468685 ↗
• MalfunctionApr 18, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED: ANGULATION WORKED BUT ANGULATION CONTROL KNOB FELT TOO LOOSE OR LIGHT. FOREIGN MATERIAL EXITED FROM THE AIR/WATER NOZZLE AND THE ADHESIVE ON THE BENDING SECTION WAS DETERIORATED. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134242 ↗
• MalfunctionMar 29, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE CUSTOMER FAILED TO INSPECT THE LEAKAGE TESTER AND MAINTENANCE UNIT BEFORE CONNECTING TO THE GASTROINTESTINAL VIDEOSCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006045 ↗
• MalfunctionMar 23, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING MANUAL CLEANING PROCESS THE SUCTION CLEANING STEPS WERE NOT BEING COMPLETED FOR THE FLEX VIDEO SCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965791 ↗
• MalfunctionMar 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909188 ↗
• MalfunctionMar 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909161 ↗
• MalfunctionMar 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909160 ↗
• MalfunctionMar 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909150 ↗
• MalfunctionMar 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909147 ↗
• MalfunctionMar 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909142 ↗
• MalfunctionFeb 23, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE HAD DARK DISTILLED BLURRY VIDEO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767341 ↗
• MalfunctionFeb 7, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL EXITING FROM THE AIR/WATER NOZZLE AND NOZZLE WAS CLOGGED WITH ADHESIVE REMOVAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664902 ↗
• MalfunctionJan 31, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE PROCEDURE WAS DIAGNOSTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611914 ↗
• MalfunctionJan 30, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THERE WERE DEVIATIONS WITH LEAK TESTING AND THE SEQUENCE OF BRUSHING DURING REPROCESSING OF THE GASTROINTESTINAL VIDEOSCOPE. THE DEVIATIONS WERE DISCUSSED WITH THE STAFF MEMBERS AND CORRECTIONS WERE MADE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606996 ↗
• MalfunctionOct 15, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER RETURNED THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE DEVICE BASED ON AN UNSPECIFIED ALLEGATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: FOREIGN MATERIAL EXITED FROM THE AIR AND WATER NOZZLE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936917 ↗
• MalfunctionSep 5, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE OLYMPUS ENDOSCOPIC SUPPORT SPECIALIST (ESS) ON BEHALF OF THE CUSTOMER REPORTED TO OLYMPUS, A POLYP WAS SUCKED UP INTO THE TRAP OF THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE. DURING THE PROCEDURE A GASTRO POLYP WAS FOUND, THE DOCTOR USED A COLD SNARE TO REMOVE THE POLYP. A TRAP WAS THEN PLACED ON THE ENDOSCOPE CONNECTOR AND WHEN THE NURSE CHECKED THE TRAP FOR A POLYP, THE STAFF NOTED A THICK PINK TINGED TAN / BROWN FROTHY SUBSTANCE IN THE TRAP (THE DOCTOR NOTED THAT NOTHING IN THE STOMACH LOOKED SIMILAR TO THE SUBSTANCE SEEN). NO LIQUID OR SUBSTANCE WAS NOTED IN THE PATIENT'S STOMACH OR ESOPHAGUS DURING THE PROCEDURE, WHICH CONCERNED THE PHYSICIAN. THE SCOPE WAS REPROCESSED / BRUSHED WITHOUT INCIDENCE, PASSED LEAK TESTS, AND THE RESI-TEST WAS NEGATIVE POST PRE-CLEANING BY CENTRAL STERILE SUPPLY (CSS), IT WAS RECOMMENDED THAT THE SCOPE BE SENT OUT TO BE CHECKED. THE ISSUE WAS FOUND DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, AND WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683247 ↗
• MalfunctionAug 24, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD AIR/WATER LEAKAGES AND FAILED THE LEAK TEST DURING REPROCESSING. UPON INSPECTION AND EVALUATION, CLOGGED AUXILIARY WATER CHANNEL. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING INCOMING INSPECTION AND EVALUATION. THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD AIR/WATER LEAKAGES AND FAILED THE LEAK TEST DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17609527 ↗
• MalfunctionAug 18, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT BIT DOWN ON DISTAL TIP OF THE SCOPE BY ACCIDENT WHEN THE BIT GUARD CAME OFF. NO KNOWN HARM DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17579306 ↗
• MalfunctionJul 21, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING AN EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE, THE ENTIRE IMAGE WAS BLURRY. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371015 ↗
• MalfunctionJul 7, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CUSTOMER REPORTED THAT THE INSERTION TUBE ON HIS OLYMPUS EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE WAS FOUND STIFF AND FAILED THE LEAK TEST DURING REPROCESSING. THIS EVENT HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278497 ↗
• MalfunctionJun 23, 2023Scratched Material; Scratched Material

  A BIOMEDICAL ENGINEER AT THE USER FACILITY REPORTED THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD IMAGE ALIGNMENT AND WHITE BALANCE ISSUES AND COULD NOT BE CHECKED BECAUSE THE IMAGE WAS NOT WORKING. IT WAS ALSO REPORTED THAT THE BENDING RUBBER SEALS AND CAMERA COVER WERE DAMAGED. THERE WAS NO PATIENT OR USER HARM REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION, CAMERA COVER DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192929 ↗
• MalfunctionMay 19, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER PROVIDED THE CLEANING STERILIZATION AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. THE CUSTOMER DID CONFIRM THAT THERE WERE NO DEVIATIONS OR DEFICIENCIES CONCERNING REPROCESSING OF THE SCOPE. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THERE WERE NO SUSPECTED PATIENT INFECTIONS DUE TO THE FACILITY FINDINGS. THE CUSTOMER DID NOT PROVIDE THE SPECIFIC STEPS TAKEN DURING THE CDS PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961170 ↗
• MalfunctionMay 17, 2023Device Reprocessing Problem; Device Reprocessing Problem

  AN OLYMPUS REPRESENTATIVE REPORTED THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE WAS REPROCESSED INCORRECTLY AND THEN USED FOR THE NEXT PROCEDURE. THERE WERE NO REPORTS OF PATIENT INFECTION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946602 ↗