EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170355462)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04953170355462), received between Nov 25, 2019 and Nov 24, 2021 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THAT DURING MAINTENANCE THE SCOPE WAS CULTURED AND TESTED KLEBSIELLA PNEUMONIAE AFTER SEVERAL CLEANINGS. THERE WAS NO ASSOCIATED PATIENT INFECTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871575 ↗
• MalfunctionMay 11, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING A STANDARD SERVICE INSPECTION, THE ASSET EVIS EXERA II ULTRASOUND GASTRO-VIDEOSCOPE'S ADHESIVE AT THE DISTAL END ELEVATOR FORCEPS COVER WAS FOUND PEELING. 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 11809775 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE WAS LEAKING FROM THE CHANNEL IRRIGATION SCREW ON THE HANDLE, AS WELL AS THE BIOPSY CHANNEL. THE SCOPE WAS WASHED IN THE MACHINE WITH THE LEAK TEST RUNNING. THE ISSUE WAS FOUND AT REPROCESSING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529775 ↗
• MalfunctionMar 16, 2021Inflation Problem; Inflation Problem

  THE SERVICE CENTER WAS INFORMED THAT THE BALLOON DOES NOT INFLATE AND WILL NOT INSUFFLATE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11493402 ↗
• MalfunctionMar 15, 2021Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY RETURNED A DEVICE FOR REPAIR DUE TO A REPORTED HOLE IN THE ULTRASOUND TIP. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE LIGHT GUIDE COVER GLUE AT THE DISTAL END WAS PEELING. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489991 ↗
• MalfunctionMar 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE EVIS EXERA II ULTRASOUND GASTOVIDEOSCOPE HAD AN ELECTRICAL CONNECTOR LOOSE AT THE CONTROL HEAD DURING THE REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474223 ↗
• MalfunctionFeb 24, 2021Fluid/Blood Leak; Peeled/Delaminated; Dent in Material; Material Split, Cut or Torn; Fluid/Blood Leak; Peeled/Delaminated; Dent in Material; Material Split, Cut or Torn

  IT IS REPORTED DURING REPROCESSING OF AN EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE, IT WAS FOUND TO HAVE A DENT ON THE INSERTION TUBE AT 430-50CM. THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372914 ↗
• MalfunctionFeb 1, 2021Degraded; Degraded

  DURING A STANDARD ANNUAL SERVICE INSPECTION OF A CUSTOMER RETURNED EVIS EXERA II ULTRASOUND GASTRO-VIDEOSCOPE THE ADHESIVE AT THE DISTAL END FORCEPS COVER WAS FOUND PEELED OFF. THERE WAS NO REPORT OF ANY PROBLEMS ASSOCIATED WITH THE DEVICE AND THERE WAS NO PATIENT INJURY OR HARM REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11257715 ↗
• MalfunctionJan 29, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED THAT DURING REPROCESSING, THE DISTAL END OF THE SCOPE WAS NOTED TO BE DAMAGE AND LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11254333 ↗
• MalfunctionJan 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT BLACK OIL WAS COMING OUT OF A GASTROVIDEOSCOPE DURING A PROCEDURE. THE PROBLEM WAS FIRST NOTICED AT THE END OF AN ENDOSCOPIC ULTRASOUND. THERE WAS NO PATIENT HARM OR INJURIES REPORTED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11239990 ↗
• MalfunctionJan 19, 2021Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11192558 ↗
• MalfunctionJan 12, 2021Defective Device; Defective Device

  DURING AN ASSET RETURN THE DEVICE WAS FOUND WITH C-BODY COVER GLUE PEELING. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11154777 ↗
• MalfunctionJan 12, 2021Defective Component; Defective Component

  THE SERVICE CENTER WAS INFORMED BY THE CUSTOMER THAT DURING PREPARATION FOR USE, THE EVIS EXERA II ULTRASOUND GASTRO-VIDEOSCOPE'S WATER JET CHANNEL WAS LOOSE. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11153923 ↗
• MalfunctionDec 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FORCEPS ELEVATOR WIRE WAS COMPLETELY CUT OFF. NO PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE IT WAS FOUND THAT THE FORCEPS COVER GLUE WAS PEELING.

  Patient problems: No Patient Involvement

  MAUDE report 11093803 ↗
• MalfunctionDec 23, 2020Mechanical Problem; Mechanical Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE, THE EVIS EXERA II ULTRASOUND GASTRO-VIDEOSCOPE WAS NOT ABLE TO RETROFLEX. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11065172 ↗
• MalfunctionDec 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING REPROCESSING, THE EVIS EXERA II ULTRASOUND GASTRO-VIDEOSCOPE WAS FOUND TO HAVE A SMALL LEAK IN THE BENDING SECTION COVER AT THE DISTAL END OF THE SCOPE. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049599 ↗
• MalfunctionDec 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED BY THE CUSTOMER THAT THE EVIS EXERA II ULTRASOUND GASTRO-VIDEO SCOPE FAILED THE LEAK TEST AND THERE WERE BUBBLES OBSERVED AT THE DISTAL END OF THE SCOPE. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11008380 ↗
• MalfunctionDec 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED THAT THE EVIS EXERA II ULTRASOUND GASTRO-VIDEO SCOPE HAS A DISTAL TIP LEAK. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10929019 ↗
• MalfunctionNov 24, 2020Break; Fluid/Blood Leak; Material Split, Cut or Torn; Break; Fluid/Blood Leak; Material Split, Cut or Torn

  IT IS REPORTED WHILE PREPARING AN EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE FOR AN UNSPECIFIED PROCEDURE, THERE WAS A COMPROMISED IMAGE DESCRIBED AS BLACK LINES APPEARING IN THE EUS IMAGE. THERE WAS NO PATIENT CONTACT/IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 10895142 ↗
• MalfunctionNov 22, 2020Device Reprocessing Problem; Device Reprocessing Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN ONSITE REPROCESSING IN-SERVICE WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS), IT WAS NOTED THAT STAFF DID NOT USE WASHING TUBES TO FLUSH EUS ELEVATOR CHANNEL DURING BEDSIDE CLEANING AND DID NOT USE THE CLEANING BRUSH AND SYRINGE TO BRUSH AND FLUSH FORCEPS ELEVATOR DURING MANUAL CLEANING. THE ESS REPORTED THAT THE FACILITY¿S GI TECHNICIANS AND LICENSED PRACTICAL NURSE (LPN) MENTIONED THEY WERE NOT AWARE OF THE CLEANING STEPS USING WASHING TUBE AND CLEANING BRUSH. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INFECTION OR DEVICE POSITIVE CULTURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10882250 ↗
• MalfunctionApr 8, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A SET UP PRE PROCEDURE, UPON INSPECTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL STUCK AT THE LIFTER LEVEL BODY OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. TO DATE THERE WAS NO PATIENT INFECTION OR HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9941132 ↗
• MalfunctionNov 25, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE INSTRUMENT CHANNEL AND THE AUXILIARY CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA, KLEBSIELLA AND MALTOPHILIA. THE DEVICE HAD BEEN REPROCESSED WITH AUTOMATIC ENDOWASHER CHYONG CYW 201 MODEL USING CIDEX FOR DISINFECTION. OTHER DETAILED INFORMATION SUCH AS THE NUMBER OF MICROBES WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9367992 ↗