Suction valve MH-443Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170071256), received between Nov 28, 2018 and Jun 5, 2026 — classified as 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Residue After Decontamination

  THE CUSTOMER REPORTED THE CLEANING BRUSH BRISTLES WERE CLOGGED IN THE SIDE HOLE OF THE SUCTION VALVE DURING A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY SCREENING. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25413475 ↗
• MalfunctionMar 19, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THE SUCTION VALVE HAD A SMALL GREEN FIBROUS FOREIGN MATERIAL THAT CAME OUT OF THE SUCTION BUTTON. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643080 ↗
• MalfunctionFeb 19, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUCTION VALVE EXHIBITED ADHESION OF FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413805 ↗
• MalfunctionAug 21, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUCTION VALVE EXHIBITED A FOREIGN OBJECT CLOGGED IN THE LATERAL HOLE OF THE "S BUTTON". THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014184 ↗
• MalfunctionJul 17, 2023Leak/Splash; Leak/Splash

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER SINCE AROUND MAY, WHEN THE DOCTOR PUTS HIS FINGER ON THE SUCTION BUTTON (SUCTION VALVE) HE FEELS DISCOMFORT WHEN WATER DROPLETS TOUCH HIS FINGERTIP. THE DEVICE WAS NOT WET FROM THE SURROUNDINGS BUT FROM WHERE THE FINGER WAS PLACED. IT IS SPECULATED THAT WATER SEEPS OUT FROM THE GAP BETWEEN THE RED DOT AND THE BLACK PART OF THE DEVICE. THE EVENT OCCURRED DURING A DIAGNOSTIC COLONOSCOPY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER USES KAIGEN WM-S, DISINFECTION WITH FUNCTIONAL WATER DURING DEVICE REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336315 ↗
• MalfunctionMay 11, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THE SUCTION VALVE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916711 ↗
• MalfunctionMar 20, 2023Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE SUCTION VALVE WAS STUCK IN THE SUCTION CHANNEL. THE ISSUE WAS FOUND DURING MAINTENANCE. THE DEVICE WAS INTENDED TO BE USED IN AN UNKNOWN DIAGNOSTIC PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE SUCTION BUTTON DID NOT COME OFF, A FOREIGN OBJECT WAS CAUGHT IN THE SUCTION CHANNEL, AND FOREIGN MATERIAL WAS ATTACHED BETWEEN TOP AND SPRING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. PATIENT IDENTIFIER: (B)(6). CAPTURES COMPLAINT ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572963 ↗
• 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 PORT CLEANING BRUSH). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-443- SUCTION VALVE(BUTTON).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291115 ↗
• MalfunctionJan 24, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE USER INFORMED CUSTOMER INFORMATION CENTER (CIC) OF OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY TELEPHONE FROM THE USER THAT THE SUBJECT DEVICE (THE SUCTION VALVES MH-443), THE AIR/WATER VALVES (MH-438), AND THE BIOPSY VALVES (MB-358) USED FOR THE ENDOSCOPES (GIF-1200N/GIF-H290/PCF-H290I/PCF-P240AI) AT THE USER FACILITY HAD BEEN SIMPLY SOAKED IN A PROTEIN REMOVER, AND THESE REPROCESSING USING THE AUTOMATED ENDOSCOPE PREPROCESSOR (MODEL NUMBER UNKNOWN) HAD BEEN PERFORMED ONLY ONCE A WEEK, AND THAT THE CHANNEL CLEANING BRUSHES (BW-20T) AND THE INJECTION TUBES (MH-946) HAD NOT BEEN REPROCESSED. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13330675 ↗
• 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 SUCTION 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 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967800 ↗
• MalfunctionAug 27, 2019Microbial 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 SAMPLE COLLECTED FROM AN UNSPECIFIED OLYMPUS PRODUCT USED IN CONJUNCTION WITH OLYMPUS ENDOSCOPES TESTED POSITIVE FOR UNSPECIFIED MICROBES (14CFU/50ML). THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (NOT AVAILABLE IN THE USA) USING PERACETIC ACID. OTHER DETAILED INFORMATION SUCH AS THE MODEL NAME WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8934229 ↗
• 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 8109633 ↗