Olympus MAJ-1606Recalls & reported problems
Quick summary
This Olympus flushing pump is used with endoscopes to pump air and fluid during exams. The 26 reports mostly describe the pump failing to pump or prime, stalling, and leaking or dripping hoses, with no deaths and no injuries mentioned. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 15019778003528), received between Mar 8, 2024 and Mar 25, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Pumping Problem” (5 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
- Pumping Problem5
- Intermittent Loss of Power4
- Crack3
- Leak/Splash3
- Failure to Pump2
- Free or Unrestricted Flow2
- Activation Failure1
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Failure to Prime
IT WAS REPORTED THAT THE FLUSHING PUMP FAILED TO PRIME DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION AND THE DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24692794 ↗MalfunctionMar 2, 2026Mechanical Jam
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP HAD A MOTOR STALLED. THE EVENT OCCURRED DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489300 ↗MalfunctionJan 28, 2026Gas/Air Leak
IT WAS REPORTED THE OLYMPUS FLUSHING PUMP HAD DRIBBLING FROM THE DISTAL END DURING A DIAGNOSTIC 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 24203829 ↗MalfunctionJan 9, 2026Pumping Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019091 ↗MalfunctionNov 21, 2025Pumping Problem; Pumping Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617332 ↗MalfunctionOct 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED THAT IRRIGATION HOSE HAS A LEAK IN IT. THE ISSUE OCCURRED DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23394484 ↗MalfunctionMay 16, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THE SUBJECT DEVICE PRESENTED A FLUSHING PUMP NOT FLUSHING. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22039706 ↗MalfunctionMay 15, 2025Pumping Problem; Pumping Problem
THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026629 ↗MalfunctionOct 29, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE IRRIGATION PUMP WAS NOT WORKING. THE ISSUE OCCURRED DURING A DIAGNOSTIC (COLONOSCOPY) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556296 ↗MalfunctionOct 7, 2024Crack; Pumping Problem; Crack; Pumping Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FAULTY PUMP HEAD AND FOUND FLOW CONTROL KNOB FRONT WAS DAMAGED WITH A CRACK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391596 ↗MalfunctionOct 7, 2024Degraded; Electrical /Electronic Property Problem; Difficult to Flush; Degraded; Electrical /Electronic Property Problem; Difficult to Flush
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLUSHING PUMP EXHIBITED FAULTY PUMP HEAD ASSY, ITS PLASTIC CAP WORN OUT AND POWER SWITCH AT FRONT FLICKERED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20388058 ↗MalfunctionSep 5, 2024Crack; Activation Failure; Material Split, Cut or Torn; Intermittent Loss of Power; Crack; Activation Failure; Material Split, Cut or Torn; Intermittent Loss of Power
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS FLUSHING PUMP EXHIBITED THAT THE UNIT FAILED TO ACTIVATE THE PUMP MOTOR WHEN FOOTSWITCH WAS PRESSED DUE FAULTY MAIN BOARD, THE POWER SWITCH LED FLICKERED, THE LED PLASTIC CAP HAS A CUT MARK, THE FRONT PANEL WAS DAMAGED WITH CRACK ON TOP LEFT CORNER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20149114 ↗MalfunctionSep 5, 2024Intermittent Loss of Power; Intermittent Loss of Power
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS FLUSHING PUMP EXHIBITED THAT THE POWER SWITCH LED FLICKERED AND FOUND WITH PLASTIC CAP WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148117 ↗MalfunctionSep 3, 2024Crack; Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THAT THE BOTTLE HOLDER WAS DAMAGED WITH A CRACK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125432 ↗MalfunctionAug 13, 2024Material Integrity Problem; Intermittent Loss of Power; Material Integrity Problem; Intermittent Loss of Power
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS FLUSHING PUMP POWER SWITCH'S LIGHT EMITTING DIODE (LED) FLICKERED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977934 ↗MalfunctionJul 10, 2024Pumping Problem; Pumping Problem
IT WAS REPORTED THAT, THE SUBJECT DEVICE HAD LACK OF PERFORMANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711249 ↗MalfunctionJun 26, 2024Intermittent Loss of Power; Intermittent Loss of Power
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLUSHING PUMP EXHIBITED POWER SWITCH LED FLICKERING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19615313 ↗MalfunctionJun 14, 2024Failure to Pump; Failure to Pump
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLUSHING PUMP EXHIBITED A FAULTY PUMP HEAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537997 ↗MalfunctionJun 10, 2024Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT THE FLUSHING PUMP'S IRRIGATION CONTINUED WHEN NO BUTTON WAS PRESSED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505029 ↗MalfunctionJun 7, 2024Circuit Failure; No Flow; Power Problem; Circuit Failure; No Flow; Power Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLUSHING PUMP EXHIBITED A FAULTY PUMP HEAD ASSEMBLY AND THE POWER SWITCH'S LED FLICKERED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19492394 ↗MalfunctionMay 13, 2024Failure to Pump; Failure to Pump
IT WAS REPORTED, DURING PREPARATION FOR USE OF AN UNSPECIFIED PROCEDURE THE SUBJECT DEVICE WAS NOT PUSHING THE WATER OUT AND IT JUST MAKES NOISE LIKE IT IS WORKING BUT IT IS NOT WORKING. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299667 ↗MalfunctionApr 25, 2024Defective Device; Defective Device
IT WAS REPORTED, THE FLUSHING PUMP HEAD WASN'T CLAMPING DOWN ON THE TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19188530 ↗MalfunctionApr 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE FLUSHING PUMP HAD WATER INFILTRATION. THE EVENT WAS FOUND DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THERE ARE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19060060 ↗MalfunctionMar 29, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE SUBJECT DEVICE WAS NOT ACTIVATING WHEN PRESSING ON THE FOOT SWITCH. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19006223 ↗MalfunctionMar 28, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THE FLUSHING PUMP HAD A LEAK UNDER THE PUMP HEAD LID. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994628 ↗
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 MAJ-1651Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope125 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.