EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (UDI 04953170339899)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04953170339899), received between Oct 11, 2018 and Aug 13, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (9 reports).

2 FDA recall records name this device's identifier, 2 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. Jan 11, 2024Class IIOpen, Classified

   Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

   Z-1209-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 13, 2026Melted

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241292 ↗
• MalfunctionMay 19, 2026No Display/Image

  IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DISPLAYED NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219937 ↗
• MalfunctionApr 10, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839311 ↗
• MalfunctionMar 30, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A FOREIGN OBJECTS AT THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730589 ↗
• MalfunctionMar 13, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE COLONOVIDEOSCOPE WAS NOT RECOGNIZED WHEN PLUGGED INTO THE VIDEO PROCESSOR. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591746 ↗
• MalfunctionFeb 23, 2026Poor Quality Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416770 ↗
• MalfunctionJan 28, 2026Overheating of Device; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED DIRT ON THE LIGHT-GUIDE COVER GLASS, A BURN ON THE LIGHT-GUIDE LENS, AND FOREIGN OBJECTS IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197173 ↗
• MalfunctionMay 28, 2025Flare or Flash; Flare or Flash

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095534 ↗
• MalfunctionMay 1, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE AIR/WATER CYLINDER, TUBE, AND JET TUBE HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941903 ↗
• MalfunctionMar 18, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635241 ↗
• MalfunctionMar 17, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, VIDEOSCOPE'S DISTAL END CONTAINED FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627596 ↗
• MalfunctionOct 12, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434916 ↗
• MalfunctionJul 25, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE'S JET TUBE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831131 ↗
• MalfunctionJul 12, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED WHITISH FOREIGN MATERIAL INSIDE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730619 ↗
• MalfunctionJun 20, 2024Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THERE WERE FOREIGN OBJECTS IN THE JET TUBE OF THE COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577809 ↗
• MalfunctionDec 20, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE LAMP AT THE FRONT DISTAL END WAS WEAKER AND THE DEVICE WAS CLEANED. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE JET TUBE HAD REMAINS OF 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 EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364600 ↗
• MalfunctionJul 8, 2021Microbial 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, ON JUN 18TH, 2021, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. AIR/WATER CHANNEL: XANTHOMONAS MALTOPHILIA (1 CFU/ENDOSCOPE). AUXILIARY CHANNEL: XANTHOMONAS MALTOPHILIA (1 CFU/ENDOSCOPE). INSTRUMENT CHANNEL: XANTHOMONAS MALTOPHILIA (34 CFU/ENDOSCOPE). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, POKA-YOKE GETINGE, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133036 ↗
• MalfunctionMay 12, 2021Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810523 ↗
• MalfunctionFeb 5, 2021Microbial Contamination of Device; Microbial Contamination of Device

  THE SERVICE CENTER WAS INFORMED THAT THE LOANER SCOPE CULTURED POSITIVE THREE TIMES. ON (B)(6) 2021, THE SCOPE¿S THIRD CULTURE SAMPLE WAS COLLECTED. THE RESULTS RECEIVED ON (B)(6) 2021, SHOWED THE SCOPE CULTURED POSITIVE FOR 50 COLONIES BACILLUS LICHENIFORMIS AND 5 COLONIES BACILLUS SPECIES. THE SCOPE WAS REPROCESSED AFTER EACH POSITIVE CULTURE BEFORE BEING RE-CULTURED. THE USER FACILITY REPORTED THAT UPON RECEIPT THE SCOPE WAS REPROCESSED AND PUT INTO QUARANTINE AWAITING RESULTS. THE SCOPE WAS NEVER PUT INTO INVENTORY OR USED ON A PATIENT AT THE FACILITY. THEREFORE, NO PATIENT INJURY OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 11286991 ↗
• MalfunctionJan 6, 2021Break; Crack; Fluid/Blood Leak; Dent in Material; Break; Crack; Fluid/Blood Leak; Dent in Material

  IT IS REPORTED DURING A PROCEDURE USING A EVIS EXERA II COLONOVIDEOSCOPE, THE ANGULATION CONTROL KNOB WAS BROKEN. THE IS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11123231 ↗
• MalfunctionDec 10, 2020Break; Positioning Problem; Break; Positioning Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE ANGULATION CABLE OF THE SCOPE BROKE. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10983735 ↗
• MalfunctionNov 16, 2020Failure to Clean Adequately; Failure to Clean Adequately

  THE SERVICE CENTER WAS INFORMED THAT THE SCOPE WAS NOT HIGH LEVEL DISINFECTED PRIOR TO PATIENT USE. THE SCOPE WAS USED IN A DIAGNOSTIC COLONOSCOPY PROCEDURE. THERE WERE NO OTHER DEVICES INVOLVED IN THE EVENT. THERE WAS NO DELAY IN THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PRIOR PATIENT HAD A HISTORY OF ANEMIA AND COLON CANCER SCREENING. THERE IS NO KNOWN INFECTION OR INJURY AT THIS TIME. NO PROPHYLACTIC MEDICATIONS WERE ADMINISTERED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10842017 ↗
• MalfunctionOct 23, 2020Microbial 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, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. ALL CHANNELS: UNSPECIFIED MICROBES (52 CFU/ENDOSCOPE). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE RE-PROCESSOR, POKA YOKE (GETINGE), USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10724953 ↗
• MalfunctionOct 14, 2020Device Reprocessing Problem; Device Reprocessing Problem

  THE USER FACILITY REPORTED THAT THE DEVICE CULTURE TESTED POSITIVE FOR BACILLUS SPECIES TWO WEEKS IN A ROW. THE FIRST CULTURE TEST WAS CONDUCTED ON (B)(6) 2020 AND THE SECOND CULTURE TEST WAS CONDUCTED ON (B)(6) 2020. THE SAMPLES WERE TAKEN FROM THE BIOPSY CHANNEL. THE DEVICE WAS REPORTED TO HAVE BEEN REPROCESSED IN OLYMPUS WASHER USING ACECIDE AND ENDOQUICK (DISINFECTANT SOLUTION). THE SCOPE WAS REPORTED TO HAVE BEEN WASHED WITH STERIS REVITAL OX SOLUTION. THERE WERE NO REPORTED PATIENT INFECTIONS ASSOCIATED WITH THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10681357 ↗
• MalfunctionOct 11, 2018Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING ROUTINE SURVEILLANCE CULTURING TESTS AT THE USER FACILITY, THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR "PAENIBACILUS" AMYLOLYTICUS (3.0CFU/ML), STAPHYLOCOCCUS WARNERI (0.1CFU/ML), AND BACILLUS "HALOSACCHARROVORANS" (0.8CFU/ML). IN THE CULTURING TEST, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE OTHER CHANNEL AND DISTAL END OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR ETD-3 (NOT AVAILABLE IN THE USA) WITH PERACETIC ACID. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7955385 ↗