4K UHD LCD MONITOR OEV321UHRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus LCD monitor for laparoscopic surgery is a display for surgical video. The 359 reports mostly describe the screen showing no image or the monitor failing to power up, and some are traced to damaged circuit boards. The reports record 2 injuries, 357 malfunctions and no deaths. 1 open recall, started in July 2026, concerns video connectors that can lead to image loss or abnormal images.
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
- 363
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 363 adverse event reports that list this exact device (DI 04953170418723), received between Feb 8, 2022 and Sep 17, 2026 — classified as 2 injuries, 361 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (190 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jul 7, 2026Class IIOpen, Classified
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Z-2761-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image190
- Failure to Power Up70
- Poor Quality Image28
- Erratic or Intermittent Display21
- Power Problem17
- Display or Visual Feedback Problem8
- Image Display Error/Artifact8
- Loss of Power8
Patient problems
- No Clinical Signs, Symptoms or Conditions363
Recent adverse event reports
The 25 most recent of 363 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Circuit Failure; Failure to Power Up
The customer returned the Olympus monitor, which is an Olympus asset with no reported complaint. During the evaluation of the device, Faulty Printed Circuit Board and Failed to Boot-Up were observed. The service repair technician indicated that the most likely cause of the Faulty Printed Circuit Board and Failed to Boot-Up was due to an electrical problem. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808884 ↗MalfunctionSep 15, 2026Circuit Failure; Failure to Power Up
The customer returned the monitor, which is an Olympus asset with no reported complaint. During the evaluation of the device, the device failed to boot-up and faulty printed circuit board was observed. The service repair technician indicated that the most likely cause of the finding was due to component failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766336 ↗MalfunctionSep 15, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765989 ↗MalfunctionSep 9, 2026Poor Quality Image
The customer reported there is a black vertical line going through the image displayed in the monitor during an inspection for use involving an Olympus monitor. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695012 ↗MalfunctionSep 9, 2026Poor Quality Image
The customer reported that the monitor was displaying the scope image only in the upper-left corner, while the remaining areas of the screen were blue, during an inspection for use involving an Olympus monitor. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694883 ↗MalfunctionAug 24, 2026No Display/Image
The customer reported that no image was present during Inspection for use involving an Olympus monitor. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419549 ↗MalfunctionAug 12, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222393 ↗MalfunctionAug 12, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221324 ↗MalfunctionAug 5, 2026No Display/Image; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144935 ↗MalfunctionAug 5, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140694 ↗MalfunctionJun 30, 2026No Display/Image
THE CUSTOMER RETURNED THE MONITOR TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE REPAIR CENTER TECHNICIAN FOUND NO FUNCTION OR IMAGE; CAUSE TRACED TO A FAULTY PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670017 ↗MalfunctionJun 19, 2026Failure to Power Up
THE CUSTOMER REPORTED NO POWER ON THE MONITOR DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS MONITOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25561761 ↗MalfunctionJun 2, 2026No Display/Image; Output Problem; Power Problem
THE CUSTOMER RETURNED THE MONITOR, AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION, THE UNIT FAILED THE POWER ON TEST, WITH NO GREEN POWER LIGHT, NO FUNCTIONAL RESPONSE, NO IMAGE, AND A FAULTY MAIN BOARD (MB 1251) OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368686 ↗MalfunctionMay 29, 2026No Device Output
THE CUSTOMER RETURNED THE MONITOR, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, POWER ON TEST HAS AMBER STANDBY LIGHT ONLY WAS OBSERVED. THE REGIONAL REPAIR CENTER INDICATED THAT THE MOST LIKELY CAUSE OF THE POWER ON TEST HAS AMBER STANDBY LIGHT ONLY WAS DUE TO BOARD FAULTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337810 ↗MalfunctionMay 25, 2026No Display/Image; Failure to Power Up; Key or Button Unresponsive/not Working
THE CUSTOMER REPORTED THAT THE OLYMPUS MONITOR WAS RECEIVING POWER INDICATED BY THE ORANGE LED (LIGHT EMITTING DIODE) BEING LIT UP, BUT UPON PRESSING THE POWER/DISPLAY BUTTON, IT DID NOT TURN GREEN AND THE BLUE OLYMPUS SPLASH SCREEN ALSO DID NOT APPEAR UPON POWERING UP THE DEVICE. MOREOVER, THE CONTROL PANEL REMAINED UNRESPONSIVE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267513 ↗MalfunctionMay 23, 2026Erratic or Intermittent Display; No Display/Image
THE CUSTOMER FACILITY¿S BIOMEDICAL ENGINEER (BIOMED) REPORTED TO OLYMPUS, A ¿DAISY CHAINED¿ MONITOR FLICKERS OR COMPLETELY BLACK OUTS WHEN THE VIDEO PROCESSOR OR SCOPE IS BUMPED. THIS MONITOR IS THE DEVICE THAT IS AT THE END OF THE ¿DAISY CHAIN¿ AND RECEIVES ITS SIGNAL FROM A SECOND MONITOR. ACCORDING TO THE BIOMED, THERE IS A CABLE THAT CONNECTS THE TWO MONITORS TOGETHER AND THE CABLE IS ROUTED MORE THAN 25 FEET AND GOES UNDER MATS ON THE FLOOR. ALTHOUGH THERE WAS NO VISIBLE DAMAGE TO THE CABLE, THE BIOMED STATED HE WILL ORDER A NEW CABLE AND REPLACE IT TO SEE IF IT WILL RESOLVE THE PROBLEM. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCEDURE. IT WAS NOTED THAT A DELAY OF LESS THAN 30 MINUTES OCCURRED, HOWEVER, THERE WERE NO REPORTS OF PATIENT OR USER INJURY RELATED TO THIS EVENT AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25265167 ↗MalfunctionMay 21, 2026Erratic or Intermittent Display
IT WAS REPORTED THE MONITOR EXPERIENCED THE VIDEO IMAGE GOES BLANK ON BOTH MONITORS WHEN A MONITOR IS MOVED DURING PROCEDURE. 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 25243685 ↗MalfunctionMay 20, 2026Failure to Power Up
IT WAS REPORTED THAT THE MONITOR WAS NOT POWERING ON. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233262 ↗MalfunctionMay 17, 2026No Display/Image
IT WAS MONITOR HAD NO IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196861 ↗MalfunctionMay 11, 2026Poor Quality Image
IT WAS REPORTED THE MONITOR HAD BLACK IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143692 ↗MalfunctionMay 3, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062845 ↗MalfunctionMay 1, 2026No Display/Image
IT WAS REPORTED THAT THE MONITOR HAD NO IMAGE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061989 ↗MalfunctionApr 28, 2026No Display/Image
IT WAS REPORTED THAT THE MONITOR HAD NO IMAGE. THE ISSUE WAS FOUND DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015738 ↗MalfunctionApr 27, 2026No Display/Image
IT WAS REPORTED THAT THE MONITOR EXHIBITED THE WIRELESS SIGNAL WAS NOT BEING DISPLAYED ON THE MONITOR. THE ISSUE WAS FOUND DURING INSPECTION FOR USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009350 ↗MalfunctionApr 27, 2026Poor Quality Image
IT WAS REPORTED THAT THE MONITOR WAS SHOWING ONLY HALF OF THE IMAGE. THE ISSUE WAS FOND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999472 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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