Biopsy ValveRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of Biopsy Valve by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2018 and Mar 30, 2026 — classified as 4 injuries, 43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Biopsy Valve problems
Device problems
- Device Contamination with Chemical or Other Material12
- Device Reprocessing Problem11
- Detachment of Device or Device Component6
- Break4
- Leak/Splash4
- Microbial Contamination of Device4
- Failure to Clean Adequately3
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient12
- Bacterial Infection1
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Biopsy Valve models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biopsy valve MB-358Gastroscope And Accessories, Flexible/Rigid36 reports
- Biopsy Valve MAJ-579Choledochoscope and accessories, flexible/rigid10 reports
- Biopsy Valve MAJ-853Endoscopic Ultrasound System, Gastroenterology-Urology1 report
Recent Biopsy Valve adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610150 ↗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 ↗MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE BIOPSY VALVE ACCESSORY WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456363 ↗MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Bacterial Infection
MAUDE report 20455444 ↗MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE BIOPSY VALVE ACCESSORY WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20454357 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434235 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434034 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433871 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE BIOPSY VALVE REPROCESSING WAS DEVIATED FROM THE REPROCESSING GUIDELINES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20432977 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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