EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (UDI 04953170237294)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04953170237294), received between Sep 11, 2018 and Nov 29, 2024 — classified as 1 death, 3 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (23 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE COLONOVIDEOSCOPE HAD INCOMPATIBLE SCOPE ERROR E315. THE SCOPE WAS REMOVED FROM THE PATIENT, SWAPPED THE PIGTAIL COMMUNICATION CABLE AND TRIED 3 DIFFERENT SCOPES BUT ERROR PERSISTED. CYCLING POWER WAS TRIED SEVERAL TIMES WHICH DID NOT CORRECT THE ISSUE. THE SCOPE WAS RESET SEVERAL TIMES AND THE ERROR WENT AWAY. THE PROCEDURE WAS CONTINUED. THE ISSUE OCCURRED DURING INSPECTION FOR USE OF A DIAGNOSTIC UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20812313 ↗
• MalfunctionOct 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE CUSTOMER ON (B)(6) 2024. ON SITE, IT WAS OBSERVED THAT SOME REPROCESSING STEPS WERE NOT DONE PER INSTRUCTIONS IN DEVIATION OF THE INSTRUCTIONS FOR USE (IFU) FOR THE PCF-H180AL. ESS COMPLETED A REPAIR REDUCTION OBSERVATION FOR THE CUSTOMER AND OBSERVED POST-PROCEDURE SET-UP, PROCEDURAL USE, BEDSIDE PRECLEANING, AND AN OBSERVATION IN THE DECONTAMINATION ROOM AS WELL, WHERE IT WAS OBSERVED LEAK TESTING WAS NOT DONE AT THIS TIME FOR MULTIPLE ENDOSCOPES, AND MANUAL CLEANING WAS DONE BUT INCOMPLETE. ESS ADVISED THE CUSTOMER OF THE MAJ-855, INSTRUCTIONS PER USE. THIS SHOULD BE REPROCESSED AFTER EACH USE; FOLLOW THE ENDOSCOPE IN THE DECONTAMINATION ROOM FOR PROPER CLEANING AND DISINFECTING. CUSTOMER HAS A THIRD-PARTY AER, INSTRUCTED TO FOLLOW INSTRUCTIONS PER THAT MANUFACTURER. IF MANUFACTURER IS NOT VALIDATED TO HIGH-LEVEL DISFECT THE MAJ-855, MANUAL HIGH-LEVEL DISINFECTION SHOULD BE PERFORMED. REFERRED CUSTOMER TO COMPATIBILITY CHART IN THE IFU. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515706 ↗
• MalfunctionSep 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE WAS OBSERVED HAVING WHITE FOREIGN MATERIAL IN THE AIR WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20288277 ↗
• MalfunctionJul 17, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL STUCK ON THE BIOPSY AND AUXILIARY WATER CHANNEL. THE ISSUE WAS FOUND AT REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764674 ↗
• MalfunctionJul 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE HAD AIR/WATER CHANNEL WAS CLOGGED DUE TO AN UNKNOWN MATERIAL INSIDE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690428 ↗
• MalfunctionJul 2, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED BY THE CUSTOMER THAT THE COLONOVIDEOSCOPE PRESENTED NO AIR/WATER FLOW WHEN PUSHING AIR AND WATER, NO WATER COMES OUT. THE ISSUE OCCURRED AFTER AN UNSPECIFIED PROCEDURE PRIOR TO BEDSIDE CLEANING. THE PROCEDURE HAD BEEN COMPLETED USING THE SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM, DEATH OR INJURY/INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661969 ↗
• MalfunctionJun 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FLEX VIDEO SCOPE EXHIBITED THAT THE CABLE SNAPPED, AND THE ANGLE WIRES BECOME UNABLE TO MOVE AND ANGULATION REMAINED LOCKED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555557 ↗
• MalfunctionJun 13, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531952 ↗
• MalfunctionJun 7, 2024Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED A TINY CHIP AROUND THE LIGHTGUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487897 ↗
• MalfunctionMay 21, 2024Separation Problem; Failure to Clean Adequately; Separation Problem; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL DUE TO GAP ON THE INSERTION SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367268 ↗
• MalfunctionMay 21, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358514 ↗
• MalfunctionApr 12, 2024Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A CLOGGED NOZZLE AND THERE WAS A LEAK FROM THE ELECTRICAL LOCKING PIN WHICH PREVENTED ADEQUATE REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101428 ↗
• MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913169 ↗
• MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913079 ↗
• MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913023 ↗
• MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912949 ↗
• MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912791 ↗
• MalfunctionMar 14, 2024No Display/Image; Image Display Error/Artifact; Communication or Transmission Problem; No Display/Image; Image Display Error/Artifact; Communication or Transmission Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE IMAGE HAD LINES, NO IMAGE, AND AN INCOMPATIBLE SCOPE ERROR (E315). THE ISSUE OCCURRED DURING A PROCEDURE AND RESULTED IN A FEW MINUTES DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE AND THERE WAS NO REPORT OF PATIENT IMPACT AND/OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904817 ↗
• MalfunctionMar 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE NOZZLE CLOGGING WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18834157 ↗
• MalfunctionMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE ANGLE WIRES WERE CUT, THE WIRE ENDS WERE UNRAVELED, WHICH RESULTED IN THE ANGLE WIRES BECOMING UNMOVABLE, AND THE ANGULATION REMAINED LOCKED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825474 ↗
• MalfunctionFeb 19, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE COLONOVIDEOSCOPE KEEPS GETTING A MESSAGE TO REPROCESS THE SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730682 ↗
• MalfunctionFeb 3, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERY AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO AND LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637136 ↗
• MalfunctionJan 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE WAS READING HIGH PRESSURE. THE ISSUE WAS FOUND DURING REPROCESSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION FOREIGN MATERIAL WAS FOUND IN THE NOZZLE AND AIR/WATER TUBE. 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 18607391 ↗
• MalfunctionDec 28, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS COLONOVIDEOSCOPE HAD NO LIGHT FROM THE LIGHT GUIDE LENS AND THE IMAGE WAS FOGGY AND DARKER. THE CUSTOMER THOUGHT THERE WAS POSSIBLE WATER INVASION AND THE CAP MAY HAVE BEEN LEFT OFF WHEN PLACED IN THE REPROCESSOR. THE ISSUE WAS FOUND DURING REPROCESSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE OBJECTIVE LENS HAD FOREIGN MATERIAL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413758 ↗
• MalfunctionDec 12, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT DURING AN ONSITE REPROCESSING IN-SERVICE AT THE CUSTOMER¿S SITE, IT WAS NOTED THAT THE COLONOVIDEOSCOPE WAS BEING IMPROPERLY REPROCESSED. THE ESS REPORTED THAT THE HAND HELD LEAK TESTER WAS USED FOR ALL SCOPES. IT WAS ALSO OBSERVED BY ESS THAT A BOTTLE LABELED WITH SIMETHICONE WAS BEING USED DURING THIS PROCESS AS WELL. THE CUSTOMER WAS INFORMED ON THE CORRECT WAY TO LEAK TEST THE ENDOSCOPE AND RECOMMENDED NOT USING THE SIMETHICONE ACCORDING TO THE REPROCESSING MANUAL. THERE WAS NO ASSOCIATED PATIENT INFECTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314245 ↗