MAINTENANCE UNIT MU-1 (UDI 04953170060427)Recalls & reported problems
Olympus Medical Systems Corp. · "MU-1 MAINTENANCE UNIT - NO CONTAINERS" · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus maintenance unit has 228 adverse event reports, all malfunctions, with no injuries and no deaths. The reports mostly describe cracked or broken power switches and inlets, and the unit failing to power up. No recalls name this device. Reports rose from 12 in the previous 12 months to 31 in the most recent 12 months.
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
- 230
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 04953170060427), received between Dec 3, 2020 and Sep 18, 2026 — classified as 230 malfunctions.
The most frequently reported specific device problem is “Break” (119 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
- Break119
- Crack37
- Failure to Power Up17
- Electrical /Electronic Property Problem14
- Material Split, Cut or Torn9
- Power Problem7
- Contamination6
- Defective Component6
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- No Consequences Or Impact To Patient4
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 230 reports, 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 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 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 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 ↗MalfunctionApr 14, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24868977 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE MAINTENANCE UNIT HAD A CRUSHED POWER SWITCH ON THE FRONT. THE PLASTIC COVERING IS MISSING, AND UNDERLYING ELECTRONICS OF THE SWITCH ARE EXPOSED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742467 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THE POWER SWITCH OF THE MAINTENANCE UNIT WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699011 ↗MalfunctionMar 25, 2026Break
IT WAS REPORTED THAT THE MAINTENANCE UNIT EXHIBITED A BROKEN POWER CONNECTOR ON THE BACK. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688321 ↗MalfunctionMar 24, 2026Crack
IT WAS REPORTED THAT THE POWER SWITCH OF THE MAINTENANCE UNIT WAS CRACKED, WE COULD SEE THE EXPOSED RESISTORS AND SOMETHING IN THE MIDDLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672308 ↗MalfunctionMar 23, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED CRACK ON ALTERNATING CURRENT INLET UNIT REAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659938 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT THE MAINTENANCE UNIT HAD A BROKEN POWER SUPPLY IN THE BACK WHERE IT PLUGS IN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388726 ↗MalfunctionFeb 13, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED ALTERNATING CURRENT (AC) INLET UNIT AT THE REAR WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330630 ↗MalfunctionFeb 9, 2026Break
IT WAS REPORTED THAT THE MAINTENANCE UNIT HAD A BROKEN POWER SWITCH. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299648 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT THE MAINTENANCE UNIT FOUND THAT THE EXTENSION CORD HAD DAMAGE TO THE TUBING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24255010 ↗MalfunctionJan 29, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MAINTENANCE UNIT EXHIBITED BROKEN ALTERNATING CURRENT (AC) INLET UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24218188 ↗MalfunctionJan 15, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080749 ↗MalfunctionDec 4, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713719 ↗MalfunctionDec 3, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704079 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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