EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XTQ160 (UDI 04953170339837)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04953170339837), received between Jul 26, 2018 and Feb 21, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND ON THE AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432242 ↗
• MalfunctionNov 21, 2024Contamination; Contamination

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749458 ↗
• MalfunctionSep 27, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITISH FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325322 ↗
• MalfunctionAug 9, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED AIR/WATER CYLINDER, AIR/WATER TUBE AND JET TUBE HAS FOREIGN OBJECT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950590 ↗
• MalfunctionMar 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE OLYMPUS DEVICE EVALUATION, THE VIDEOSCOPE HAD A FOREIGN MATERIAL (NON-OLYMPUS PLASTIC VALVE) STUCK WITHIN THE INSUFFLATION CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867066 ↗
• MalfunctionFeb 6, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD BEEN RECONDITIONED SEVERAL TIMES AFTER REPAIR AND HAD FAILED EACH TIME WITH MOLD INFESTATION IN THE WORKING CHANNEL. 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 18651362 ↗
• MalfunctionDec 12, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE PROXIMAL END TO HANDLE WAS BENT ON THE GASTROINTESTINAL VIDEOSCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, WHITE FOREIGN REMAINS WERE FOUND IN THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310157 ↗
• MalfunctionDec 2, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUES WERE FOUND DURING REGULAR EXAMINATION IN THE HOSPITAL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253273 ↗
• MalfunctionDec 1, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT DESPITE CAREFULLY CLEANING THE GASTROINTESTINAL VIDEOSCOPE WITH A TOOTHBRUSH, IT APPEARED DIRTY (CLOT). A CHECK IS REQUESTED TO VERIFY THE INTEGRITY OF THE INTERNAL MESH, PERFORATED (EXPOSED METAL). THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE WHITE FOREIGN MATERIAL WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244214 ↗
• MalfunctionNov 20, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE HAD GLUE RESIDUE IN THE CHANNEL AND ON THE OUTSIDE OF THE SOCK. THE ISSUE WAS FOUND DURING A THERAPEUTIC GLUE FUNDUS VARICES PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170111 ↗
• MalfunctionOct 27, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL VIDEOSCOPE HAD A DEFECTIVE LENS OR CAMERA. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE JET TUBE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18025246 ↗
• MalfunctionOct 13, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. 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 17932824 ↗
• MalfunctionOct 4, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE HAD A FOREIGN BODY STUCK INSIDE OF THE SCOPE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPYGLASS PROCEDURE, THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, AND WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868768 ↗
• MalfunctionAug 7, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION ON THE SWAB OF THE DISTAL END. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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 17471240 ↗
• MalfunctionJul 28, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR CONTAMINATION. DESPITE REPEATED WASHING INCLUDING TESTING, GERMS WERE FOUND. DURING REPROCESSING, STAPHYLOCOCCI WERE FOUND AT THE DISTAL END AND THE AUXILIARY CHANNEL. THE USER DID NOT REPORT ANY OTHER CONTAMINATION OR 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 17414333 ↗
• MalfunctionJul 6, 2023Contamination; Contamination

  A CUSTOMER REPORTED POOR AIR SUPPLY FROM THE EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. UPON INSPECTION AND TESTING, THE NOZZLE WAS CLOGGED WITH FOREIGN MATERIAL. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266688 ↗
• MalfunctionJun 21, 2023Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE HAD AIR/WATER DUCT DEFECTIVE. DURING INSPECTION AND EVALUATION, FOREIGN MATERIALS WERE FOUND INSIDE THE NOZZLE, AT THE OBJECTIVE LENS ADHESIVE AND AT THE SUCTION CYLINDER. AT THE SUCTION CYLINDER AND OBJECTIVE LENS ADHESIVE WAS FOUND A BROWN PARCHED FOREIGN MATERIAL. INSIDE THE NOZZLE WAS FOUND ALSO THE BROWN PARCHED FOREIGN MATERIAL BUT MIXED WITH WHITE FIBERS. 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 MALFUNCTION FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17176571 ↗
• MalfunctionJun 8, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE HAD GLUE ON THE OUTSIDE OF THE THERAPY SCOPE AND GLUE ON MOUTH TO THE WORKING CHANNEL. MOST LIKELY THERE IS GLUE INSIDE THE WORKING CHANNEL AS WELL DURING A GASTROSCOPY, ENDOSCOPIC INJECTION TREATMENT IN THE STOMACH INCLUDING PYLORUS FOR A THERAPEUTIC PROCEDURE. DURING INSPECTION AND EVALUATION, THERE WAS SOME MESS IN THE CHANNEL (IT CANNOT BE DENIED THAT THIS ENDOSCOPE MAY HAVE BEEN USED IN THE PROCEDURE WHILE THIS FOREIGN MATERIAL WAS PRESENT IN THIS ENDOSCOPE.) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090642 ↗
• MalfunctionApr 28, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THAT WHEN USING AN EVIS EXERA GASTROINTESTINAL VIDEOSCOPE, THERE WAS AIR LEAKAGE AT THE DISTAL END. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED. AND UPON ESTIMATION, THERE WAS FOREIGN MATERIAL IN THE AIR/WATER TUBE. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837814 ↗
• MalfunctionApr 13, 2023Poor Quality Image; Poor Quality Image

  THE SUBJECT DEVICE WAS RECEIVED, AT AN OLYMPUS SERVICE CENTER FOR EVALUATION, WITH A REPORT THAT THE IMAGE WAS GREENISH. THERE WAS NO PATIENT OR USER INJURY REPORTED. DURING INSPECTION AND TESTING, SERVICE FOUND THE ENDOSCOPIC IMAGE WAS BLURRY. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION [BLURRED IMAGE] FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735759 ↗
• MalfunctionMar 31, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISTAL END OF THE GASTROINTESTINAL VIDEOSCOPE WAS DAMAGED. THE DEVICE WAS RETURNED AND AN EVALUATION OF THE RETURNED DEVICE REVEALED PRESENCE OF FOREIGN MATERIAL IN THE FORCEPS CHANNEL PORT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654461 ↗
• MalfunctionFeb 23, 2023Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Device Contamination with Chemical or Other Material; Failure to Clean Adequately

  A CUSTOMER REPORTED TO OLYMPUS, WASHING DOES NOT GO THROUGH THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE. THE CONNECTED HOSES CAME LOOSE AND SHOWED PRESSURE BEING TOO HIGH. THE CHANNELS WERE BRUSHED THOROUGHLY BUT THERE MAY HAVE BEEN A BLOCKAGE IN ONE OF THE CHANNELS. THE EVENT OCCURRED WHILE IN THE DISHWASHER DURING REPROCESSING. THE DISHWASHER BEEPED DIFFERENT ERRORS EACH TIME. THE LEAK TEST PASSED. THE INTENDED PROCEDURE WAS A GASTROSCOPY THAT WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433406 ↗
• MalfunctionDec 29, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THE CONTAMINATION LEVELS OF THE EVIS EXERA GASTROINTESTINAL VIDEOSCOPE WERE TOO HIGH. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070108 ↗
• MalfunctionDec 18, 2022Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT A GASTROINSTESTINAL VIDEOSCOPE HAD A BLURRY IMAGE, UNABLE TO GET A CLEAR IMAGE AND ONLY ABLE TO SEE COLOR. THE REPORTED ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001455 ↗
• MalfunctionJun 29, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THE SHEATH OF THE SUBJECT DEVICE WAS DAMAGED. THE REPORTED ISSUE WAS NOTICED AFTER AN EGDS (ENDOSCOPIC HEMOSTASIS FOR VARICEAL HEMORRHAGE) PROCEDURE. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETE USING THE SUBJECT DEVICE. THE DEVICE HAD BEEN INSPECTED PRIOR TO THE INTENDED PROCEDURE AND NO ANOMALIES WERE OBSERVED. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, SERVICE FOUND THERE WAS FOREIGN MATERIAL LODGED AT THE DISTAL END AREA, IN THE INSTRUMENT CHANNEL AND THE AUXILIARY WATER CHANNEL (J-CHANNEL). IN ADDITION, THE SAME FOREIGN MATERIAL WAS FOUND ON THE PLASTIC DISTAL END COVER (C-COVER) AND THE BENDING SECTION COVER (A-RUBBER). THE CONNECTING TUBE WAS STICKY DUE TO THE SAME FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION OF THE DEVICE (FOREIGN MATERIAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853294 ↗