Air/water valve MH-438Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170071249), received between Nov 28, 2018 and Feb 11, 2026 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER VALVE EXHIBITED CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314037 ↗
• MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER VALVE'S SEALS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624908 ↗
• MalfunctionDec 11, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE THEIR AIR/ WATER VALVE HAD THE FOLLOWING CONCERN; THE AIR/WATER SUPPLY BUTTON COULD NOT BE OPERATED. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION IT WAS DETERMINED THAT THE FOLLOWING REPORTABLE EVENTS WERE IDENTIFIED; FOREIGN MATERIAL WAS ON THE AIR/ WATER SUPPLY BUTTON. THERE WAS NO PATIENT HARM, PROCEDURAL DELAY, OR INJURY AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301413 ↗
• MalfunctionSep 14, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT FOLLOWING A COMPLETED REPROCESSING CYCLE WITH HIS OLYMPUS AIR/WATER VALVE, HE PRESSED ONE OF THE BUTTONS AND A TRANSPARENT FIBROUS MATERIAL CAME OUT FROM THE SPRING. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744145 ↗
• MalfunctionJun 2, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, A CULTURE TEST DETECTED UNSPECIFIED COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA FROM RANDOMLY SELECTED DEVICES. SAMPLES WERE COLLECTED SOON AFTER REPROCESSING ON TWO DIFFERENT DATES. PRE-CLEANING WAS PERFORMED USING SARAYA'S POWER QUICK AND DISINFECTION WAS PERFORMED USING OER-4 REPROCESSOR. 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. THIS REPORT CAPTURES COMPLAINT ON AIR/WATER VALVE (MODEL: MH-438; SERIAL NUMBER: UNKNOWN) RELATED PATIENT IDENTIFIERS: (B)(6) CAPTURES COMPLAINT ON SCOPE (MODEL:PCF-H290ZI; SERIAL NUMBER: (B)(6)) (B)(6) CAPTURES COMPLAINT ON BIOPSY VALVE (MB-358; SERIAL NUMBER UNKNOWN) (B)(6) CAPTURES COMPLAINT ON GAS WATER VALVE (MODEL: MAJ-2010; SERIAL NUMBER: UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050944 ↗
• MalfunctionDec 21, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS BACTERIA NOTED ON THE SUCTION BUTTON AND FORCEPS PLUG. CLEANING AND DISINFECTION METHOD WAS PERFORMED ACCORDING TO THE INSTRUCTION MANUAL. THE BUTTONS ARE ALSO ULTRASONICALLY CLEANED. IT WAS REPORTED THAT AFTER RETESTING, NO BACTERIA WAS DETECTED WHEN TESTED UNDER THE SAME CONDITIONS. THE FACILITY USES THE OER-3 AND OER-4 FOR REPROCESSING. THERE WAS NO REPORTS OF PATIENT INFECTION OR HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030854 ↗
• MalfunctionDec 9, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER, THEY ARE USING A 3RD PARTY WATER BOTTLE AND CAPS WHILE REPROCESSING OLYMPUS SCOPES. THE WATER FROM THE BOTTLES ACTS AS IF THEY ARE BEING DEPRESSED WITH THE AIR/WATER VALVE. THE CUSTOMER IS REPROCESSING THE SUBJECT DEVICE DIFFERENTLY FROM THE INSTRUCTION MANUAL. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950024 ↗
• MalfunctionNov 4, 2022Contamination; Failure to Clean Adequately; Contamination; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE AIR/WATER VALVE AND SUCTION VALVE WERE PLACED ON A GAUZE FOR DRYING FOR A DAY AFTER THEY WERE WASHED. THE GAUZE WAS SPREAD ON THE TIP WHERE EACH PART WAS STORED TOGETHER. THE GAUZE TURNED YELLOWISH AND DIRTY. THE USER REQUESTED ANALYSIS OF THE COMPOSITION OF THE DIRT. THE CDS (CLEANING, DISINFECTION, AND STERILIZATION) METHOD USED WAS END CLEANSE. IT WAS ALSO REPORTED, THAT CONTAMINATION DID NOT OCCUR ON A PARTICULAR VALVE AND WAS HAPPENING ALL ALONG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734835 ↗
• MalfunctionAug 25, 2022Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT WHEN THE FACILITY MEDICAL STAFF WAS CLEANING THE AIR/WATER SUPPLY BUTTON, SUCTION BUTTON WITH MH-507 (CLEANING BRUSH), AND THE BRUSH COULD NOT PASS THROUGH THE HOLE OF THE AIR/WATER SUPPLY BUTTON. THE OLYMPUS REPRESENTATIVE THEN INFORMED THE CUSTOMER THE CORRECT REPROCESSING PROCEDURE BY USING THE BW-20T CHANNEL CLEANING BRUSH. THE ISSUE FOUND DURING REPROCESSING AND THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES THREE (3) REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-438- AIR/WATER VALVE (BUTTON). REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-443- SUCTION VALVE(BUTTON). REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-507-CHANNEL OPENING CLEANING BRUSH). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-438- AIR/WATER VALVE (BUTTON).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15290899 ↗
• MalfunctionAug 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE, HER OLYMPUS AIR/WATER VALVE BEGAN LEAKING. ACCORDING TO THE INITIAL REPORTER, THE SUBJECT DEVICE WAS STILL USED TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138214 ↗
• MalfunctionJan 24, 2022Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE SUBJECT DEVICE HAS BEEN SIMPLY SOAKED IN A PROTEIN REMOVER AND HAS REPROCESSED WITH AN AUTOMATED ENDOSCOPE "REPROCESSORONE" ONLY ONCE A WEEK. THIS REPROCESSING IS INCORRECT AND MAY HAVE BEEN INSUFFICIENT REPROCESSED (THE USER MAY HAVE USED THE POOR REPROCESSING SUBJECT DEVICE FOR NEXT PROCEDURE). IN ADDITION, THE USER REQUESTED TO OLYMPUS TO INSTRUCT THE CORRECT REPROCESSING WAY. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13332946 ↗
• MalfunctionJun 9, 2021Device Reprocessing Problem; Device Reprocessing Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN ONSITE REPROCESSING OBSERVATION WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS) IT WAS NOTED THAT THE CUSTOMER NOT BRUSHING OR FLUSHING THE AIR/WATER VALVE DURING MANUAL CLEANING. THE CUSTOMER WAS ALSO SKIPPING CLEANING STEPS ON THE LEAK TESTING, AIR WATER CLEANING ADAPTER, SUCTION VALVE, AIR WATER VALVE, AND BIOPSY BUTTON. THERE WAS NO PATIENT INFECTION, PATIENT INVOLVEMENT OR DEVICE POSITIVE CULTURE REPORTED. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967761 ↗
• DeathJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT DIED AFTER AN ENDOSCOPIC PROCEDURE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WITH THE SUBJECT DEVICE. THE USER FACILITY REQUESTED OLYMPUS TO FIND OUT IF THE DEVICE HAS ANY PROBLEMS. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: Death

  MAUDE report 10104491 ↗
• MalfunctionApr 2, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR ENTEROBACTER CLOACAE, STENOTROPHOMONAS MALTOPHILIA AND CANDIDA TROPICALIS DURING A ROUTINE SURVEILLANCE CULTURING TEST BY THE FACILITY. THE PORTION OF THE SUBJECT DEVICE, WHERE THE MICROBES WERE DETECTED, HAD NOT BEEN REPORTED. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-3 (NOT AVAILABLE IN THE USA). THE FACILITY REPORTED THAT THE SUBJECT DEVICE WAS TAKEN OUT FROM THE AUTOMATED ENDOSCOPE REPROCESSOR WITH AN UNSTERILIZED GLOVE AFTER THE REPROCESSING AND THEY COMMENTED THAT THE HANDLING POSSIBLY CONTRIBUTED TO THE EVENT. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8472597 ↗
• MalfunctionNov 28, 2018Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IN THE TWO TIMES MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE MICROBES WERE DETECTED FROM SAMPLES TAKEN FROM THE SUBJECT DEVICE. THE TYPE AND NUMBER OF MICROBES ARE UNKNOWN. THE DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-3 OR OER-4 WITH PERACETIC ACID. THEN, NO MICROBE WAS DETECTED FROM SAMPLES TAKEN FROM THE DEVICE IN THE THIRD TIME MICROBIOLOGICAL TESTING AFTER THE USER FACILITY REPROCESSED THE DEVICE BY STEAM STERILIZATION (AUTOCLAVING). THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109627 ↗