MAINTENANCE UNITRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 377
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 2 models of MAINTENANCE UNIT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 377 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2020 and Sep 18, 2026 — classified as 3 injuries, 374 malfunctions.
The most frequently reported specific device problem is “Break” (197 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 MAINTENANCE UNIT problems
Device problems
- Break197
- Crack51
- Failure to Power Up25
- Electrical /Electronic Property Problem23
- Power Problem15
- Defective Component11
- Material Split, Cut or Torn11
- Contamination9
Patient problems
- No Clinical Signs, Symptoms or Conditions350
- No Patient Involvement13
- No Consequences Or Impact To Patient12
- Electric Shock3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
MAINTENANCE UNIT models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAINTENANCE UNIT MU-1Colonoscope and accessories, flexible/rigid230 reports
- MAINTENANCE UNIT MU-1Colonoscope And Accessories, Flexible/Rigid147 reports
Recent MAINTENANCE UNIT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
The customer reported that the power cord inlet on the back of the maintenance unit was broken. This issue was identified during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817831 ↗MalfunctionSep 10, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720736 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058173 ↗MalfunctionJun 26, 2026Crack
THE CUSTOMER RETURNED THE MAINTENANCE UNIT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE AC INLET UNIT REAR WAS DAMAGED WITH A CRACK AND THE PLASTIC CAP ON POWER SWITCH FRONT WAS TORN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636035 ↗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 ↗MalfunctionJun 19, 2026Break; Corroded
THE CUSTOMER RETURNED THE MAINTENANCE UNIT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE SERVICE REPAIR TECHNICIAN, INDICATES THAT A POWER SWITCH DAMAGED WITH PLASTIC COVER MISSING AND RUST AND LIQUID MARKS INSIDE TUBING WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25568049 ↗MalfunctionJun 3, 2026Break
THE CUSTOMER RETURNED THE MAINTENANCE UNIT TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD BROKEN POWER SWITCH EXPOSING INTERNAL COMPONENTS AND DAMAGED REAR ELECTRICAL INLET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375069 ↗MalfunctionMay 28, 2026Crack
THE CUSTOMER RETURNED THE MAINTENANCE UNIT TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD CRACKED POWER INLET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323433 ↗MalfunctionMay 12, 2026Failure to Power Up
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED POWER SWITCH DOES NOT LIGHT UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147973 ↗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 ↗MalfunctionMay 5, 2026Break; Loose or Intermittent Connection
IT WAS REPORTED THAT THE MAINTENANCE UNIT HAD BROKEN POWER CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25084630 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT THE MAINTENANCE UNIT HAD A TORN PLASTIC COVERING ON THE FRONT POWER BUTTON. 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 24983677 ↗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 22, 2026Crack; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED INLET UNIT AT REAR WAS DAMAGED AND CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953032 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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