Biopsy valve MB-358Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04953170063947), received between Nov 28, 2018 and Mar 30, 2026 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (12 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BIOPSY VALVE EXHIBITED SCRATCH LIKE TRACE AROUND THE SLIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730210 ↗
• InjuryJan 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A COMPONENT OF THE BIOPSY VALVE DETACHED DURING STENT INSERTION. THE DETACHED COMPONENT WAS IDENTIFIED NEAR THE PATIENT¿S DUODENAL PAPILLA AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158372 ↗
• MalfunctionOct 21, 2025Device Reprocessing Problem; Device Reprocessing Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348703 ↗
• MalfunctionMay 13, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED ADHESION OF A WHITE SUBSTANCE ON BIOPSY VALVE LID. THE ISSUE OCCURRED DURING REPROCESSING FOR A DIAGNOSTIC UPPER ENDOSCOPY/COLONOSCOPY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008846 ↗
• MalfunctionMay 6, 2025Material Discolored; Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Material Discolored; Device Contamination with Chemical or Other Material; Failure to Clean Adequately

  IT WAS REPORTED THAT AFTER CLEANING, THE LID PART OF THE BIOPSY VALVE, WHICH IS STORED DRY, HAS TURNED WHITE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970198 ↗
• InjuryFeb 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BRONCHOSCOPY PROCEDURE, AFTER THE BIOPSIES WERE COMPLETED, A FRAGMENT OF THE BIOPSY VALVE FELL OFF INTO THE PATIENT'S BRONCHUS. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A GRASPING FORCEPS. THE PROCEDURE WAS DELAYED BUT THE EXACT TIME WAS UNKNOWN; IT WAS THOUGHT TO BE LESS THAN 30 MINUTES. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294146 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE LID OF THE FORCEPS STOPPER ON THE BIOPSY VALVE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168354 ↗
• MalfunctionApr 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BIOPSY VALVE HAD BODY FLUIDS AND FILTH LEAKING FROM THE BROKEN PART OF THE FORCEPS STOPPER. THE ISSUE OCCURRED DURING THE UPPER ENDOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164462 ↗
• MalfunctionJan 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN A PHYSICIAN PASSED THE BIOPSY FORCEPS THROUGH THE SLIT OF THE BIOPSY VALVE FORCEPS PLUG A LARGE HOLE WAS MADE IN THE SLIT OF THE LID SECTION. THE ISSUE WAS FOUND DURING A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597207 ↗
• InjuryJan 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A USER FACILITY REPORTED WHEN THEY INSERTED THE SEMI-DISPOSABLE FORCEPS PLUG (MB-358) INTO THE FORCEPS FROM ABOVE THE LID (WITHOUT OPENING THE LID), PART OF THE LID OF THE FORCEPS PLUG BROKE AND FELL INTO THE PATIENT'S BODY. THE EVENT OCCURRED DURING AN UPPER ENDOSCOPY. THE DAMAGED LID WAS RECOVERED AND THERE WAS NO HEALTH HAZARD TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577094 ↗
• MalfunctionJan 12, 2024Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT THAT THE GASTROINTESTINAL VIDEOSCOPE / BIOPSY VALVE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE. THE BACTERIA - KLEBSIELLA PNEUMONIAE (+) AND SERRATIA MARCESCENS (+) WERE DETECTED IN THE SUCTION LINE/FORCEPS PLUG. 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 IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6) FOR THE VIDEOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504321 ↗
• InjuryOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: THE LIQUID SENT WHEN THE PROBLEM OCCURRED WAS "MINCLEAR INTERNAL SPRAY LIQUID." IT IS A DRUG THAT COMES IN A SYRINGE-LIKE CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990959 ↗
• MalfunctionOct 12, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO OLYMPUS, THE BIOPSY VALVE WAS LEAKING. DURING THE TEST, LIQUID LEAKED LIKE WATER, PROBABLY DUE TO BACKFLOW FROM THE FORCEPS PLUG. LEAKAGE OCCURS EVEN WHEN NOTHING IS BEING DONE DURING AND AFTER FEEDING THE LIQUID WITH THE SYRINGE. THE CUSTOMER REPLACED IT WITH A NEW ONE FROM THE SAME LOT, BUT NO IMPROVEMENT WAS SEEN. THERE ARE NO DEFECTS SUCH AS HOLES VISIBLE ON THE EXTERIOR. THE PROCEDURE WAS PERFORMED AND COMPLETED WITH FLUID LEAKING. THERE ARE NO HEALTH HAZARDS DUE TO THIS DEFECT. THE ISSUE WAS FOUND DURING A COLONOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924383 ↗
• 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 BIOPSY VALVE (MB-358; SERIAL NUMBER UNKNOWN) RELATED PATIENT IDENTIFIERS: (B)(6) CAPTURES COMPLAINT ON SCOPE (MODEL:PCF-H290ZI; SERIAL NUMBER: (B)(6)). (B)(6) CAPTURES COMPLAINT ON AIR/WATER VALVE (MODEL: MH-438; 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 17050148 ↗
• MalfunctionFeb 17, 2023Defective Component; Defective Component

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, WHEN UNPACKING A NEW BIOPSY VALVE AND INSERTED FORCEPS THE SLIT DID NOT RETURN WHEN FORCEPS WAS REMOVED. THE EVENT OCCURRED DURING A DIAGNOSTIC BIOPSY. THE INTENDED PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE (155PB-0506) WITHOUT ANY DELAYS. A DEVICE PRE-USE CHECK WAS PERFORMED, AND NO ABNORMALITIES WERE FOUND. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401312 ↗
• 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 STOPPER. 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 16030895 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT LIQUID WAS LEAKING BETWEEN THE FORCEPS PLUG AND THE PLUG MOUTHPIECE ON THE OLYMPUS BIOPSY VALVE. ACCORDING TO THE INITIAL REPORTER, THE FORCEPS PLUG COMES OFF FROM THE MOUTHPIECE DUE TO WATER PRESSURE WHEN THE SYRINGE IS FED. REPORTEDLY, THE PHYSICIAN SWITCHED TO A SPARE DEVICE IN ORDER TO COMPLETE THE PROCEDURE. NO HARM OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13474578 ↗
• MalfunctionJan 19, 2022Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE SUCTION VALVE MH-443, AIR/WATER VALVE MH-438, AND BIOPSY VALVE MB-358 USED FOR THE ENDOSCOPE AT THE FACILITY HAD BEEN SIMPLY SOAKED IN A PROTEIN REMOVER, AND REPROCESSED WITH AN AUTOMATED ENDOSCOPE REPROCESSOR ONLY ONCE A WEEK. ALSO, NO REPROCESSING OF CLEANING BRUSH BW-20T OR INJECTION TUBE MH-946 HAD BEEN IMPLEMENTED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE EVENT DATE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13298836 ↗
• MalfunctionJan 5, 2022Break; Leak/Splash; Break; Leak/Splash

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE FIRST USE IN UNSPECIFIED PROCEDURE, THE SLIT WAS DAMAGED AND THE PATIENT'S BODY FLUIDS OR FILTH LEAKED FROM AIR/WATER VALVE, SUCTION VALVE OR THE BIOPSY VALVE. THE USER REPLACED IT WITH ANOTHER DEVICE BUT SAME ISSUE OCCURRED. SINCE THERE WAS NO PROBLEM WITH THE PROCEDURE, THE USER USED IT AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13163423 ↗
• MalfunctionJan 5, 2022Break; Leak/Splash; Break; Leak/Splash

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE FIRST USE IN UNSPECIFIED PROCEDURE, THE SLIT WAS DAMAGED AND THE PATIENT'S BODY FLUIDS OR FILTH LEAKED FROM AIR/WATER VALVE, SUCTION VALVE OR THE BIOPSY VALVE. THE USER REPLACED IT WITH THE SUBJECT DEVICE BUT SAME ISSUE OCCURRED. SINCE THERE WAS NO PROBLEM WITH THE PROCEDURE, THE USER USED IT AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13163184 ↗
• MalfunctionDec 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT AFTER THE REPROCESS OF THE SUBJECT DEVICE WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-5 (NOT AVAILABLE IN THE USA) IT WAS FOUND THAT WHITE CRYSTALS HAD ADHERED ON THE CAP OF THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13050689 ↗
• MalfunctionJun 21, 2021Failure to Clean Adequately; Failure to Clean Adequately

  AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT DURING A REPAIR REDUCTION OBSERVATION AT THE USER FACILITY, THE BIOPSY VALVE WAS BEING REPROCESSED INCORRECTLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036204 ↗
• MalfunctionDec 11, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A USER REPORTED THAT WHITE FOREIGN MATTER REMAINED ON THE MB-358 AFTER CLEANING AND DISINFECTING MB-358. THE CUSTOMER REPROCESSED THIS DEVICE USING OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR AND A NON-OLYMPUS ONE, BUT THEY SAW THE ISSUE IN EITHER CASE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10990365 ↗
• MalfunctionDec 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PART INSIDE THE FORCEPS CAP FELL OFF INTO THE PATIENT'S BODY. THE USER COLLECTED THE DROPPED PART. THE USER REPLACED THE DEVICE WITH A SIMILAR DEVICE AND COMPLETED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURIES RELATED TO THIS INCIDENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10940158 ↗
• MalfunctionSep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE HEMOSTASIS OF THE ENDOSCOPIC MUCOSAL RESECTION WITH THE BIOPSY VALVE MB-358 AND CF-H290I, A THERAPEUTIC PRODUCT DIDN'T PASS THROUGH THE INSTRUMENT CHANNEL OF THE CF-H290I. WHEN THE CUSTOMER INSERTED A CLEANING BRUSH INTO THE CHANNEL OF CF-H290I, A FRAGMENT OF THE BIOPSY VALVE CAME OUT OF THE CHANNEL AND FELL OFF INTO THE PATIENT'S BODY. BASED ON X-RAY, THE USER DECIDED NOT TO RETRIEVE THE FRAGMENT AND TO LET IT GO OUT OF THE BODY NATURALLY. THERE WAS NO REPORT OF THE PATIENT INJURY. THIS IS A REPORT FOR THE THE BIOPSY VALVE MB-358.

  Patient problems: Foreign Body In Patient

  MAUDE report 10506723 ↗