EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170355479)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 04953170355479), received between Sep 13, 2019 and Sep 22, 2021 — classified as 86 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (33 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2021Partial Blockage; Partial Blockage

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNKNOWN PROCEDURE, A NEEDLE WAS STUCK IN THE INSTRUMENT CHANNEL ON THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514219 ↗
• MalfunctionSep 20, 2021Peeled/Delaminated; Peeled/Delaminated

  THIS DEVICE WAS SENT IN FOR REPAIR FOR BUBBLING FOUND IN S-CONNECTOR LOCATED NEAR THE AIR/WATER SUPPLY CONNECTOR DURING THE LEAK TEST IN REPROCESSING OF THE DEVICE. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT. DURING REPAIR INSPECTION, IT WAS OBSERVED THAT THE LIGHT GUIDE COVER GLUE WAS PEELING. THIS MEDWATCH IS BEING SUBMITTED FOR THE ISSUE OF THE LIGHT GUIDE COVER GLUE PEELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497868 ↗
• MalfunctionSep 17, 2021Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY REPORTED TO OLYMPUS THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE PRESENTED A SHADOW ON THE SCREEN WHEN PLUGGED INTO THE PROCESSOR. THERE WAS NO REPORT OF PATIENT OR USER HARM OR INJURY DUE TO THE EVENT. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE ADHESIVE WAS FOUND TO BE PEELING OFF THE DISTAL END. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492257 ↗
• MalfunctionMay 26, 2021Crack; Peeled/Delaminated; Naturally Worn; Crack; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT WHEN CLEANING THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE, THE BRUSH GOT STUCK. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885557 ↗
• MalfunctionMay 21, 2021Image Display Error/Artifact; Peeled/Delaminated; Image Display Error/Artifact; Peeled/Delaminated

  IT WAS REPORTED, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE EXPERIENCED AN E311 ERROR DURING USE. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864135 ↗
• MalfunctionMay 19, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT LEAK AT DISTAL TIP OF THE DEVICE WAS OBSERVED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848243 ↗
• MalfunctionMay 17, 2021Complete Blockage; Complete Blockage

  THE SERVICE CENTER WAS INFORMED THAT THE BIOPSY CHANNEL IS BLOCKED AND THE FORCEPS CANNOT BE INSERTED OR REMOVED FROM THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837916 ↗
• MalfunctionMay 13, 2021Peeled/Delaminated; Material Puncture/Hole; Peeled/Delaminated; Material Puncture/Hole

  IT WAS REPORTED, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE'S DISTAL END HAD A HOLE. THIS EVENT OCCURRED DURING REPROCESSING AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820524 ↗
• MalfunctionMay 12, 2021Leak/Splash; Defective Component; Component Missing; Leak/Splash; Defective Component; Component Missing

  THE DEVICE FAILED LEAK TEST DURING REPROCESSING WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811759 ↗
• MalfunctionMay 10, 2021Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  LEAKS WERE REPORTED ON THE DEVICE. THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802461 ↗
• MalfunctionMay 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS RETURNED FOR REPAIR OF A LEAK AND THE ISSUE OF FORCEPS COVER MISSING AT THE DISTAL END WAS OBSERVED AT THE TIME OF INSPECTION. THERE IS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796983 ↗
• MalfunctionMay 6, 2021Fluid/Blood Leak; Peeled/Delaminated; Fluid/Blood Leak; Peeled/Delaminated

  AS REPORTED, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE FAILED A LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784240 ↗
• MalfunctionApr 29, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING A STANDARD SERVICE INSPECTION, THE ASSET EVIS EXERA II ULTRASOUND GASTRO-VIDEOSCOPE'S ADHESIVE AT THE DISTAL FOREPS COVER PEELED OFF. THERE WAS NO REPORTED ALLEGATION OF ANY MALFUNCTION ASSOCIATED WITH THE DEVICE AND THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743163 ↗
• MalfunctionApr 28, 2021Peeled/Delaminated; Peeled/Delaminated

  THE HIGH DEFINITION (HD) 3CMOS CAMERA HEAD WAS RETURNED TO THE OLYMPUS SERVICE CENTER WITH NO REPORTED ALLEGATION OF A MALFUNCTION. DURING THE EVALUATION, THE SERVICE CENTER IDENTIFIED A MALFUNCTION OF PEELING ADHESIVE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740658 ↗
• MalfunctionApr 12, 2021Failure to Clean Adequately; Failure to Clean Adequately

  AT THE BEGINNING OF AN ENDOSCOPIC ULTRASOUND IN-SERVICE WITH STERILE PROCESSING TECHNICIANS AT THE USER FACILITY, THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS INFORMED THAT THE FACILITY IS NOT CURRENTLY USING THE PROPER CLEANING BRUSH DURING THE REPROCESSING OF A ULTRASOUND GASTRO-VIDEOSCOPE. NO PATIENT INJURY, INFECTION OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654079 ↗
• MalfunctionApr 9, 2021No Display/Image; No Display/Image

  DURING PREPARATION FOR USE OF AN UNSPECIFIED DIAGNOSTIC PROCEDURE, THE EVIS EXERA II ULTRASOUND GASTRO-VIDEO SCOPE REPORTEDLY HAD NO IMAGE, NO PICTURES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646362 ↗
• MalfunctionApr 6, 2021Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR REPAIR AND THE ISSUE OF FORCEPS COVER GLUE PEELING WAS OBSERVED AT THE TIME OF ESTIMATION. THERE IS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623012 ↗
• MalfunctionApr 6, 2021Fluid/Blood Leak; Peeled/Delaminated; Material Split, Cut or Torn; Fluid/Blood Leak; Peeled/Delaminated; Material Split, Cut or Torn

  IT IS REPORTED AN EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE HAD LEAKAGE FROM THE DISTAL END DUE TO A TEAR IN THE TIP. THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619641 ↗
• MalfunctionApr 5, 2021Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR REPAIR AND THE ISSUE OF FORCEPS COVER GLUE PEELING WAS OBSERVED AT THE TIME OF INSPECTION. THERE IS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614643 ↗
• MalfunctionApr 2, 2021Fluid/Blood Leak; Peeled/Delaminated; Fluid/Blood Leak; Peeled/Delaminated

  CORRECTED INFORMATION: AS REPORTED BY THE USER, THE DEVICE HAD NO IMAGE DURING PREPARATION FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607418 ↗
• MalfunctionMar 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  DURING A STANDARD SERVICE INSPECTION, THE ASSET EVIS EXERA II ULTRASOUND GASTRO-VIDEO ENDOSCOPE'S ADHESIVE AT THE DISTAL END FORCEPS COVER WAS FOUND PEELED OFF. THERE WAS NO REPORT OF ANY PROBLEMS ASSOCIATED WITH THE ASSET SCOPE AND THERE WAS NO REPORT OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556396 ↗
• MalfunctionMar 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  DURING A STANDARD SERVICE INSPECTION, THE ASSET EVIS EXERA II ULTRASOUND GASTRO-VIDEO ENDOSCOPE'S ADHESIVE AT THE DISTAL END FORCEPS COVER WAS PEELING / MISSING. THERE WAS NO REPORT OF ANY PROBLEMS ASSOCIATED WITH THE ASSET AND NO REPORT OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555675 ↗
• MalfunctionMar 22, 2021Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY RETURNED THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE TO OLYMPUS FOR REPAIR DUE TO A REPORTED CRACKED BUTTON #1. UPON EVALUATION OF THE RETURNED DEVICE, PEELING OF THE FORCEPS COVER GLUE WAS NOTED. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546389 ↗
• MalfunctionMar 19, 2021Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THERE HAVE BEEN NO REPORTS OF PATIENT INFECTION AND/OR INJURY ASSOCIATED WITH THE SUBJECT SCOPE AND THE PROBLEM OF FORCEPS COVER GLUE PEELING, FOUND BY OLYMPUS DURING EVALUATION OF THE RETURNED SUBJECT SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530763 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED THAT AFTER THE SCOPE WAS REPROCESSED AND KEPT FAILING LEAK TEST. THE SCOPE CAPS WERE CHANGED MULTIPLES TIMES AND A BLACK "INK" WOULD LEAK OUT. THE CUSTOMER REPORTED THAT IF THE SCOPE COULD NOT BE PLACED IN THE FACILITY¿S MEDIVATORS AUTOMATIC ENDOSCOPE REPROCESSOR (AER) A LIQUID DISINFECTANT SOLUTION (PRODUCT UNKNOWN) WAS POURED INTO THE SCOPE. THE SOLUTION WOULD REMAIN IN THE SCOPE FOR A FEW MINUTES AND THEN THE SCOPE WOULD BE RINSED. THE CUSTOMER NOTED THAT IF THE SOLUTION WAS NOT COMPLETELY RINSED FROM THE SCOPE A BLACK INK LIKE SUBSTANCE WOULD LEAK OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529030 ↗