MAINTENANCE UNIT MU-1 (REF 5685852)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Quick summary
This Olympus MU-1 maintenance unit is used to maintain endoscopes. Its 148 reports describe breaking or cracked parts, power inlets and switches failing, and fluid getting into the unit, and some mention a dirty pump tube. The reports include 3 injuries and no deaths. 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
- 147
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 04953170060434), received between Oct 26, 2020 and Jun 24, 2026 — classified as 3 injuries, 144 malfunctions.
The most frequently reported specific device problem is “Break” (78 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
- Break78
- Crack14
- Electrical /Electronic Property Problem9
- Failure to Power Up8
- Power Problem8
- Defective Component5
- Failure to Clean Adequately5
- Contamination3
Patient problems
- No Clinical Signs, Symptoms or Conditions127
- No Patient Involvement10
- No Consequences Or Impact To Patient8
- Electric Shock3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Material Discolored; Failure to Clean Adequately
THE CUSTOMER RETURNED THE MAINTENANCE UNIT TO THE SERVICE CENTER FOR AN SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN NOTED YELLOWING OF THE PUMP TUBE, STAINS ON THE PUMP TUBE, AND THAT THE INTERNAL TUBE WAS DIRTY AND YELLOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25609259 ↗MalfunctionMay 11, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT HAD DAMAGE TO THE POWER SWITCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144130 ↗MalfunctionMay 8, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED A DAMAGED POWER INLET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25131258 ↗MalfunctionApr 23, 2026Leak/Splash
IT WAS REPORTED THAT MAINTENANCE UNIT HAD FLUID INVASION. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975184 ↗MalfunctionApr 13, 2026No Device Output; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED MISSING CAP AND FAULTY POWER SWITCH LIGHT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861943 ↗MalfunctionApr 9, 2026Connection Problem
IT WAS REPORTED THAT THE MAINTENANCE UNIT POWER INLET IS BROKEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836058 ↗MalfunctionMar 23, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT HAD DAMAGE ON THE INLET PLUG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661532 ↗MalfunctionMar 18, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT HAD CRUSHED POWER SWITCH, AND IT IS MECHANICALLY DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625566 ↗MalfunctionMar 18, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT HAD A DETERIORATED INLET PLUG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625532 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT THE MAINTENANCE UNIT HAD A DAMAGED PLUG DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24622188 ↗MalfunctionMar 17, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXIBITED BROKEN POWER SWITCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621028 ↗MalfunctionMar 9, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT HAD EXHIBITED A POWER SOCKET FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548340 ↗MalfunctionMar 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT HAD A DETACHED INLET PLUG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24529994 ↗MalfunctionFeb 27, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT PRESENTED DEFECTIVE MAINS SWITCH WITH COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475278 ↗MalfunctionFeb 2, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED A BROKEN INLET PLUG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24229199 ↗MalfunctionOct 27, 2025Crack; Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED THE INLET PLUG IS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23397796 ↗MalfunctionOct 22, 2025Break; Break
NO NEW ADDITIONAL INFORMAL RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23361981 ↗MalfunctionAug 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD TRIPPED THE FI (FAULT INTERRUPTER) AND EXHIBITED A HIGHER PROTECTIVE CONDUCTOR LEAKAGE CURRENT DURING SETUP AND INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873374 ↗MalfunctionAug 21, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22867399 ↗MalfunctionMay 15, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22032445 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A POWER SWITCH BROKEN, THE ISSUE OCCURRED DURING SERVICE MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751777 ↗MalfunctionMar 28, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BROKEN LIGHT BULB IN THE SWITCH. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21722129 ↗MalfunctionMar 27, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DETERIORATION OF TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713870 ↗MalfunctionMar 17, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DIRT ON CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21627822 ↗MalfunctionMar 5, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GI IMAGING EXHIBITED A TUBE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525705 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.