Olympus MAJ-1651Recalls & reported problems
Quick summary
This Olympus flushing pump used with endoscopes has 116 adverse event reports on file. Some describe the pump failing to pump or flow properly, others describe water leaking, and others describe buttons that do not respond. The reports include no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 125
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 15019778004716), received between Apr 23, 2024 and Sep 30, 2026 — classified as 125 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (17 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash17
- Pumping Problem17
- Key or Button Unresponsive/not Working11
- Infusion or Flow Problem8
- Break7
- Degraded4
- Fluid/Blood Leak4
- Improper Flow or Infusion4
Patient problems
- No Clinical Signs, Symptoms or Conditions125
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash
The customer reported constantly leaking water, and the amber light was indicating that there was an internal issue during inspection for use involving an Olympus flushing pump. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944660 ↗MalfunctionSep 22, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855772 ↗MalfunctionSep 21, 2026Activation Failure
The customer reported that they had to run the pump using the foot pedal to adjust the flow rate during inspection for use involving an Olympus Flushing Pump. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842366 ↗MalfunctionSep 21, 2026Improper Flow or Infusion; Key or Button Unresponsive/not Working
The customer reported that it was unable to adjust the pump speed for an olympus flushing pump. During the initial evaluation of the device, the flow rate was observed to be out of specification in air water suction. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841549 ↗MalfunctionSep 17, 2026Failure to Clean Adequately
The customer returned the Olympus flushing pump with no customer allegation. During the initial evaluation of the returned device, a brown and black substance was observed in the water bottle. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804088 ↗MalfunctionSep 10, 2026Improper Flow or Infusion; Key or Button Unresponsive/not Working
The customer reported an issue with the front keypad and was unable to adjust the flow during an unspecified procedure involving an Olympus Flushing Pump. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704861 ↗MalfunctionAug 26, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463940 ↗MalfunctionAug 11, 2026Leak/Splash; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209014 ↗MalfunctionAug 6, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160263 ↗MalfunctionAug 6, 2026Leak/Splash; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160116 ↗MalfunctionAug 6, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159425 ↗MalfunctionAug 4, 2026Contamination
The customer returned the Olympus Flushing Pump, which is an Olympus asset with no reported complaint. During the device evaluation, biohazard contamination was observed in the water bottle. There was no patient involvement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130054 ↗MalfunctionJul 29, 2026Break; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076850 ↗MalfunctionJun 20, 2026Overheating of Device
THE CUSTOMER RETURNED THE OLYMPUS FLUSHING PUMP TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING THE REPAIR CENTER TECHNICIAN FOUND BURNED FRONT PANEL LIGHT EMITTING DIODE, CAUSE TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25569599 ↗MalfunctionMay 26, 2026Leak/Splash
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP HAD A WATER LEAK. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278764 ↗MalfunctionMay 21, 2026Infusion or Flow Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS FLUSHING PUMP FLOW SETTING CANNOT BE ADJUSTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241967 ↗MalfunctionMay 6, 2026Pumping Problem
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP EXHIBITED CAPTURED PATIENT IMPACT UNIT WAS BECOMING LOAD AND FAILING TO WORK AS EXPECTED . THE ISSUE OCCURRED DURING UNKNOWN PROCEDURE, WHICH WAS COMPLETED USING THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093711 ↗MalfunctionApr 17, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS FLUSHING PUMP PRESENTED A SUBSTANCE INGRESS INSIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912427 ↗MalfunctionMar 9, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLOW RATE OF OLYMPUS FLUSHING PUMP WAS OUT OF SPECIFICATIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544863 ↗MalfunctionMar 6, 2026Inability to Irrigate
IT WAS REPORTED THE IRRIGATION OF THE OLYMPUS FLUSHING PUMP WAS NOT FUNCTIONING PROPERLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532395 ↗MalfunctionFeb 25, 2026Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446463 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368564 ↗MalfunctionFeb 9, 2026Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291516 ↗MalfunctionFeb 2, 2026Inability to Irrigate
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP HAD IRRIGATION ADJUSTMENT NOT FUNCTIONING. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235326 ↗MalfunctionJan 28, 2026Pressure Problem; Key or Button Unresponsive/not Working
IT WAS REPORTED THE PANEL SWITCH OF THE FLUSHING PUMP WAS NOT WORKING PROPERLY, CAUSING THE INABILITY TO ADJUST WATER PRESSURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24198925 ↗
Other Pump, Air, Non-Manual, For Endoscope devices
- OLYMPUS OFP-2 (ROW)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope296 reports
- Olympus WB991046OLYMPUS Winter & Ibe GmbH · Pump, Air, Non-Manual, For Endoscope81 reports
- ERBEFLO CleverCap® 20325-239Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall24 reports
- OLYMPUS OFP-2 (US)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope1 recall22 reports
- ERBEFLO CleverCap® 20325-206Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall5 reports
- ERBEFLO CleverCap® 20325-248Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-240Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-208Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.