AUXILIARY WATER TUBE MAJ-855 (UDI 04953170071508)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04953170071508), received between Feb 6, 2019 and Mar 3, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Corroded” (10 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Failure to Clean Adequately

  IT WAS REPORTED THAT DURING EVALUATION, THE AUXILIARY WATER TUBE WAS NOT HIGH-LEVEL DISINFECTED BETWEEN USES AND WAS ONLY MANUALLY CLEANED WITH DETERGENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494434 ↗
• MalfunctionOct 2, 2024Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS NOT FOLLOWING THE PRECLEANING STEPS, THE AUXILIARY WATER TUBE WAS NOT USED AS PER INSTRUCTIONS FOR USE, THE FLUSHING PUMP WAS NOT PRESSED FOR 10 SECONDS AS THE LAST STEP IN PRECLEANING AND THE DEVICE DID NOT TRAVEL WITH THE ENDOSCOPE TO GET REPROCESS. THEREFORE, PRE-CLEANING, NOR MANUAL CLEANING, AS WELL AS HIGH-LEVEL DISINFECTANT LEVEL WERE NOT PERFORM CORRECTLY. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355712 ↗
• MalfunctionJul 17, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE SUB-WATER SUPPLY PORT OF THE AUXILIARY WATER TUBE WAS CLOGGED. THE ISSUE WAS FOUND DURING REPROCESSING FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE THAT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761916 ↗
• MalfunctionMay 7, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE AUXILIARY WATER TUBE WAS BEING INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264164 ↗
• MalfunctionNov 1, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REQUESTED AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST CONDUCT A REPROCESSING IN-SERVICE. WHILE ONSITE, IT WAS DISCOVERED THE CUSTOMER WAS NOT REPROCESSING THE AUXILIARY WATER TUBE, SUCTION CLEANING ADAPTER, AND INJECTION TUBE AFTER EACH USE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052557 ↗
• InjurySep 12, 2023Device Reprocessing Problem; Problem with Removal of Enzymatic Cleaner; Failure to Clean Adequately; Device Reprocessing Problem; Problem with Removal of Enzymatic Cleaner; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE AUXILIARY WATER TUBE WAS MISTAKENLY USED IN COMBINATION WITH A FLUSHING PUMP IN AN UNDISINFECTED AND UNSTERILIZED STATE AT THE FACILITY IN AN ENDOSCOPY CASE. IT WAS REPORTED THAT THE FACILITY HAD TWO WATER TUBES, ONE WAS USED FOR INSPECTION AND THE OTHER WAS USED FOR REPROCESSING. THE FACILITY MISTAKENLY USED THE WATER TUBE FOR REPROCESSING DURING A CASE AND AS A RESULT, THE PATIENT MAY HAVE INGESTED ENDOFRESH WHICH REMAINED IN THE WATER TUBE PIPELINE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733319 ↗
• InjuryJul 17, 2023Residue After Decontamination; Residue After Decontamination

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THREE CASE REPORTS OF GLUTARALDEHYDE-INDUCED CHEMICAL COLITIS." CURRENTLY, CHEMICAL COLITIS IN CLINICAL PRACTICE IS MAINLY CAUSED BY IATROGENIC FACTORS. THE DISINFECTANT GLUTARALDEHYDE IS ONE OF THE COMMON DRUGS THAT CAN CAUSE CHEMICAL COLITIS, BUT THERE ARE FEW REPORTS ABOUT IT. FROM AUGUST 2019 TO AUGUST 2022, 1457 CASES OF COLONOSCOPY WERE PERFORMED IN THE ENDOSCOPY ROOM OF THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE AND SONGYANG COUNTY PEOPLE¿S HOSPITAL, AND 3 CASES OF CHEMICAL COLITIS CAUSED BY GLUTARALDEHYDE RESIDUE ARE DISCUSSED IN THIS REPORT. ALL 3 CASES OCCURRED ON THE SAME ENDOSCOPIC SYSTEM AND SAME DAY. THESE 3 PATIENTS WERE HOSPITALIZED AND TREATED WITH BOWEL REST, HYDRATION, PERORAL KANGFUXIN SOLUTION, DEXAMETHASONE COMBINED WITH KANGFUXIN SOLUTION LOCAL ENEMA TREATMENT, AND EMPIRIC ANTIBIOTIC. IN CONCLUSION, STANDARDIZED MANAGEMENT OF CLEANING AND DISINFECTION SHOULD BE STRENGTHENED IN DEPARTMENTS CARRYING OUT ENTEROSCOPY, ESPECIALLY THOSE USING THE CONCENTRATED GLUTARALDEHYDE IMMERSION SOLUTION AND CLEANING AFTER IMMERSION, TO PREVENT THE OCCURRENCE OF ACUTE CHEMICAL ENTERITIS RELATED TO

  Patient problems: Abdominal Pain; Chemical Exposure; Gastrointestinal Hemorrhage; Hyperemia; Swelling/ Edema; Ulcer

  MAUDE report 17333189 ↗
• InjuryJul 17, 2023Residue After Decontamination; Residue After Decontamination

  ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR CONFIRMS NO DEVICE MALFUNCTION OR ADVERSE EVENT OCCURRED WHEN USING OLYMPUS DEVICES.

  Patient problems: Abdominal Pain; Chemical Exposure; Gastrointestinal Hemorrhage; Hyperemia

  MAUDE report 17333098 ↗
• InjuryJul 17, 2023Residue After Decontamination; Residue After Decontamination

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THREE CASE REPORTS OF GLUTARALDEHYDE-INDUCED CHEMICAL COLITIS." CURRENTLY, CHEMICAL COLITIS IN CLINICAL PRACTICE IS MAINLY CAUSED BY IATROGENIC FACTORS. THE DISINFECTANT GLUTARALDEHYDE IS ONE OF THE COMMON DRUGS THAT CAN CAUSE CHEMICAL COLITIS, BUT THERE ARE FEW REPORTS ABOUT IT. FROM AUGUST 2019 TO AUGUST 2022, 1457 CASES OF COLONOSCOPY WERE PERFORMED IN THE ENDOSCOPY ROOM OF THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE AND SONGYANG COUNTY PEOPLE¿S HOSPITAL, AND 3 CASES OF CHEMICAL COLITIS CAUSED BY GLUTARALDEHYDE RESIDUE ARE DISCUSSED IN THIS REPORT. ALL 3 CASES OCCURRED ON THE SAME ENDOSCOPIC SYSTEM AND SAME DAY. THESE 3 PATIENTS WERE HOSPITALIZED AND TREATED WITH BOWEL REST, HYDRATION, PERORAL KANGFUXIN SOLUTION, DEXAMETHASONE COMBINED WITH KANGFUXIN SOLUTION LOCAL ENEMA TREATMENT, AND EMPIRIC ANTIBIOTIC. IN CONCLUSION, STANDARDIZED MANAGEMENT OF CLEANING AND DISINFECTION SHOULD BE STRENGTHENED IN DEPARTMENTS CARRYING OUT ENTEROSCOPY, ESPECIALLY THOSE USING THE CONCENTRATED GLUTARALDEHYDE IMMERSION SOLUTION AND CLEANING AFTER IMMERSION, TO PREVENT THE OCCURRENCE OF ACUTE CHEMICAL ENTERITIS RELATED TO

  Patient problems: Abdominal Pain; Chemical Exposure; Gastrointestinal Hemorrhage; High White Blood Cell Count; Swelling/ Edema; Ulcer

  MAUDE report 17332996 ↗
• MalfunctionJun 28, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE FIELD SERVICE ENGINEER (FSE) REPORTED TO OLYMPUS, THE AUXILIARY WATER TUBE WAS NOT REPROCESSED CORRECTLY. IT WAS NOTED THAT THE MAJ-855 TUBING WAS FREELY IN THE BASIN WITH NO CONNECTION TO HIGH LEVEL DISINFECT. THERE WAS ALSO CONNECTORS A1,B1,C1,D1 TWO SETS FREELY BEING REPROCESSED AT THAT TIME. THE LIDS OF THE WASHING BASIN WERE OFF AND ONLY THREE OF THE FOUR COULD BE FOUND. IT WAS REPORTED THAT WHEN REPROCESSING A SINGLE DILATOR WITH A SCOPE, THE DILATOR WAS CONNECTED BY THE ORANGE CONNECTOR D2 WITH A LURE LOCK NEEDLE ATTACHED TO THE D2 CONNECTOR. THIS CONNECTOR IS USED TO REPROCESS THE MAJ-855 TUBING AND THE AUX CHANNEL OF THE SCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222434 ↗
• MalfunctionMay 5, 2023Contamination; Contamination

  A NURSE AT THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THERE WAS A BACKFLOW OF BLOOD IN THE AUXILIARY WATER TUBE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, IT WAS FOUND THAT FOREIGN MATERIAL ADHERED TO THE CONNECTING SECTION OF THE AUXILIARY WATER TUBE AND AUXILIARY WATER INLET. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876769 ↗
• MalfunctionNov 10, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS RETURNED TO THE FACILITY BY OLYMPUS WITH A PLASTIC ACCESSORY STUCK INSIDE. THE EVENT WAS DISCOVERED WHEN THE DEVICE WAS RECEIVED AND THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775421 ↗
• MalfunctionNov 9, 2022Contamination; Contamination

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, DURING REPROCESSING AFTER USE OF THE DEVICE, IT WAS OBSERVED THAT SOME FOREIGN MATERIAL WAS CLOGGING AND MOVING INSIDE THE LURE MOUTHPIECE WHILE CLEANING. THE CLEANING STAFF TRIED TO PUSH THE MATERIAL WITH A NEEDLE, BUT THE MATERIAL ONLY WENT IN DEEPER. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762905 ↗
• MalfunctionOct 21, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THE SUBJECT DEVICE WAS ATTACHED TO THE ENDOSCOPE DURING AN UNSPECIFIED PROCEDURE BUT CAME OFF EASILY. THERE WAS NO IMPACT TO THE TESTING AND NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, FOREIGN MATERIAL WAS FOUND INSIDE THE DEVICE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (FOREIGN MATERIAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655431 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15304719 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15304332 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15304069 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303854 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303842 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303675 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303606 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303435 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303308 ↗
• MalfunctionAug 26, 2022Corroded; Corroded

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING VISUAL INSPECTION OF THE DEVICE AT THE TIME OF REPROCESSING, IT WAS OBSERVED THAT RUST WAS GENERATED FROM THE METAL PART INSIDE THE TUBE. THE NUMBER OF TIMES OF USE AND THE PERIOD OF USE AFTER DELIVERY ARE UNKNOWN. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303172 ↗
• MalfunctionAug 24, 2022Contamination; Contamination

  THE CUSTOMER REPORTED AFTER AUTOCLAVING THE SUBJECT DEVICE, IT WAS OBSERVED THERE WAS BROWN FOREIGN MATERIAL ON THE BASE OF THE DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. REPORTEDLY, THE CUSTOMER SUSPECTED THAT THE MOUTHPIECE OF THE SUBJECT DEVICE WAS MELTED. HOWEVER, IT WAS LATER CONFIRMED THERE WAS FOREIGN MATERIAL ADHERED ON THE OUTSIDE OF THE MOUTHPIECE RATHER THAN MELTED. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF FOREIGN MATERIAL ON MOUTHPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15284281 ↗