EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170341793)Recalls & reported problems

Summary

The FDA's MAUDE database contains 210 adverse event reports that list this exact device (DI 04953170341793), received between May 21, 2020 and Sep 30, 2026 — classified as 1 injury, 209 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (81 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 210 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, gap between acoustic lens and ultrasound probe was observed. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945811 ↗
• MalfunctionJun 19, 2026Crack; Degraded

  THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THE ADHESIVE AROUND OBJECTIVE LENS HAD A CHIP AND THE ADHESIVE AROUND THE LIGHT LIGHT LENS HAD WEAR. THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566327 ↗
• MalfunctionMay 4, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE'S ADHESIVE AROUND THE LIGHT GUIDE LENS HAD WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075878 ↗
• MalfunctionJan 20, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED THE ADHESIVE AROUND OBJECTIVE LENS HAS WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24124468 ↗
• MalfunctionJan 15, 2026Crack; Peeled/Delaminated; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED A CHIP AT THE ACOUSTIC LENS, A SCRATCH AT ACOUSTIC LENS WHICH REACHES THE GLUE LAYER AND A GAP BETWEEN ACOUSTIC LENS AND ULTRASOUND PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083115 ↗
• MalfunctionNov 19, 2025Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE ULTRASOUND GASTROVIDEOSCOPE 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 23600568 ↗
• MalfunctionSep 3, 2025Microbial Contamination of Device; Microbial Contamination of Device

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952353 ↗
• MalfunctionNov 26, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE EXHIBITED THE NOZZLE. AND KNOB WIRE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786743 ↗
• MalfunctionNov 26, 2024Break; Pitted; Material Split, Cut or Torn; Break; Pitted; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE EXHIBITED A DEEP CUT AND PARTS BROKEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785888 ↗
• MalfunctionNov 25, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROVIDEOSCOPE'S BENDING SECTION COVER, OR DISTAL SHEATH AND KNOB WIRE, HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775402 ↗
• MalfunctionNov 25, 2024Crack; Crack

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED DISTAL END HAD A CRACK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771103 ↗
• MalfunctionNov 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED DAMAGE REACHING THE GLUE-LAYER ON THE ACOUSTIC LENS AND INSUFFICIENT INSULATION RESISTANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761899 ↗
• MalfunctionNov 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THERE WERE FOREIGN OBJECTS ON THE FORCEPS ELEVATOR WIRE OF THE GASTROVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758850 ↗
• MalfunctionNov 22, 2024Device Reprocessing Problem; Material Erosion; Scratched Material; Device Reprocessing Problem; Material Erosion; Scratched Material

  DURING THE DEVICE INSPECTION, IT WAS OBSERVED THAT THE ACOUSTIC LENS WAS DAMAGED/SCRATCHED AND THE DAMAGE REACHED THE ADHESIVE LAYER. AS A RESULT, THE INSULATION RESISTANCE VALUE WAS OUT OF STANDARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758335 ↗
• MalfunctionNov 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE KNOB WIRE/FORCEPS ELEVATOR WIRE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756449 ↗
• MalfunctionNov 5, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THERE WAS FOREIGN MATERIAL ON THE BENDING SECTION COVER ADHESIVE OF THE GASTROINTESTINAL VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611015 ↗
• MalfunctionNov 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WHILE EVALUATING A RETURNED OLYMPUS EVIS EXERA ULTRASOUND GASTROVIDEOSCOPE IT WAS DISCOVERED THAT THE K-WIRE HAD FOREIGN MATERIAL PRESENT. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610103 ↗
• MalfunctionOct 30, 2024Scratched Material; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED A SCRATCH THAT REACHED THE ADHESIVE LAYER ON THE ACOUSTIC LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570382 ↗
• MalfunctionOct 17, 2024Scratched Material; Scratched Material

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED A SCRATCH ON THE ACOUSTIC LENS THAT REACHES TO THE GLUE-LAYER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478200 ↗
• MalfunctionOct 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROVIDEOSCOPE EXHIBITED A CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465524 ↗
• MalfunctionOct 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE DUODENOVIDEOSCOPE EXHIBITED THE FORCEPS-WIRE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462699 ↗
• MalfunctionOct 15, 2024Defective Component; Defective Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED ULTRASOUND PROBE WERE DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453435 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, IT WAS OBSERVED THAT A RESIDUAL WHITISH FOREIGN MATERIAL WAS FOUND INSIDE THE JET-TUBE. THE USE OF PRODUCTS THAT CONTAIN SILICONE CAN CAUSE DEPOSITS OF WHITE FOREIGN MATERIAL. IF THE CUSTOMER USED THEM, THERE WAS RISK THAT FOREIGN MATERIAL WAS REMAINED IN THE CHANNEL EVEN IF THE REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH IFU. SIMETHICONE AND PETROLEUM/OIL/SILICONE-BASED LUBRICANTS ARE NON-WATER SOLUBLE AND THUS NOT RECOMMENDED FOR USE BY OLYMPUS. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433491 ↗
• MalfunctionOct 9, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE GASTROVIDEOSCOPE HAD IMAGE NOT CLEAR BLACK PATCH INSIDE THE IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408880 ↗
• MalfunctionOct 2, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROVIDEOSCOPE EXHIBITED ISSUES DUE TO CLOGGING OF THE BALLOON WATER TUBE, PREVENTING THE BALLOON CHANNEL CLEANING BRUSH FROM BEING INSERTED SMOOTHLY. THE BENDING SECTION COVER CONTAINED FOREIGN OBJECTS, AND THE KNOB WIRE ALSO HAD FOREIGN MATERIAL PRESENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352416 ↗