3D VISUALIZATION UNIT OLYMPUS 3DV-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04953170338229), received between Jan 8, 2021 and Jul 27, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (21 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035736 ↗
• MalfunctionApr 20, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE 3D VISUALIZATION UNIT EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926131 ↗
• MalfunctionMar 6, 2026No Display/Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536330 ↗
• MalfunctionJan 28, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT THE 3D VISUALIZATION UNIT HAD NOT OUTPUT 2D IMAGES CORRECTLY. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198985 ↗
• MalfunctionAug 6, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED POWER BUTTON SUNKEN AND THE MAIN BUTTON SWITCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728506 ↗
• MalfunctionMay 13, 2025No Display/Image; No Display/Image

  THE SUBJECT DEVICE WAS REPORTED TO EXHIBIT A BLACK SCREEN WHEN TURNED ON. THE EVENT OCCURRED DURING SETUP/INSPECTION FOR USE BEFORE THE PATIENT WAS IN THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011296 ↗
• MalfunctionMar 17, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD DARK IMAGE. THE ISSUE WAS FOUND DURING THE SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625623 ↗
• MalfunctionJan 24, 2025Output Problem; Output Problem

  IT WAS REPORTED THE SUBJECT DEVICE HAD E402 DF NOT CONNECTED ERROR. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233426 ↗
• MalfunctionJan 13, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THE 3D VISUALIZATION UNIT IS NOT ABLE TO GET 2D OR 3D IMAGES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140711 ↗
• MalfunctionDec 5, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD BLACKOUT. THE ISSUE WAS FOUND, DURING SEDATION. FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE. THAT WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853125 ↗
• MalfunctionOct 17, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  THE CUSTOMER REPORTED THAT DURING PREPARATION FOR A THERAPEUTIC PROCEDURE, HIS OLYMPUS 3D VISUALIZATION UNIT WAS EXPERIENCING AN INTERMITTENT IMAGE. ACCORDING TO THE INITIAL REPORTER, THE INTENDED PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE WITHOUT ANY REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471779 ↗
• MalfunctionAug 14, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED, THE 3D VISUALIZATION UNIT SIGNAL FROM THE SERIAL DIGITAL INTERFACE TWO BACK PORT OUTPUT CREATED NOISE AND FLICKERING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983487 ↗
• MalfunctionJun 19, 2024Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT THE VISUALIZATION UNIT WHEN CONNECTED WITH THE MAIN MONITOR COULD NOT OUTPUT A 3D IMAGE. THE IMAGE APPEARED TO BE OUT OF ALIGNMENT. THE ISSUE OCCURRED AT PREPARATION FOR US FOR A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571094 ↗
• MalfunctionJan 24, 2024No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  IT WAS REPORTED, THE 3D VISUALIZATION UNIT HAD A FAULTY SWITCH; THE POWER BUTTON FLASHES OCCASIONALLY WHEN TURNING ON THE PHONE, AND THERE IS NO SIGNAL ON THE SCREEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576417 ↗
• MalfunctionJan 19, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE 3D VISUALIZATION UNIT'S POWER BUTTON WAS DEFECTIVE; WHEN POWERED UP, IT DID NOT STAY ON. THIS OCCURRED DURING PREPARATION FOR USE, AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547936 ↗
• MalfunctionJan 18, 2024Defective Component; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS, THAT NO LIGHT-EMITTING DIODE (LED) WAS HIGHLIGHTED ON THE PANEL OF THE 3D VISUALIZATION UNIT. THE ISSUE WAS FOUND DURING PREPARATION FOR A THERAPEUTIC LAPAROSCOPIC DONOR NEPHRECTOMY. THE PROCEDURE WAS COMPLETED WITH A NON-OLYMPUS DEVICE AND NO PROCEDURAL DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534926 ↗
• MalfunctionJan 4, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE 3D VISUALIZATION UNIT HAD AN IMAGE PROBLEM. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18448831 ↗
• MalfunctionAug 2, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE 3D VISUALIZATION UNIT EXPERIENCED A NO IMAGE ISSUE. THE EVENT WAS FOUND DURING PROCEDURE. THE INTENDED PROCEDURE (THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH)) WAS NOT DELAYED. THERE WAS NO IMPACT, HARM OR INJURY TO THE USER OR PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445761 ↗
• MalfunctionJul 25, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE 3D VISUALIZATION UNIT TOWER WAS SETUP AND HAD NO IMAGE TO THE SLAVE MONITOR. THE ISSUE WAS FOUND AT THE BEGINNING OF A PROCEDURE. THE CASE WAS MOVED TO A DIFFERENT ROOM, WHEN THEY COULD NOT GET THE MONITOR TO WORK. HOWEVER, THE TECHNICIAN WAS ABLE TO GET IT WORKING AGAIN BY SELECTING THE CORRECT VIDEO SETTINGS BEFORE THE NEXT PLANNED PROCEDURE FOR THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390156 ↗
• MalfunctionMay 19, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE 3D VISUALIZATION UNIT WAS NOT WORKING PROPERLY, NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970129 ↗
• MalfunctionMay 10, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED, A 3D SCOPE CONNECTED TO 3DV-190 TOWER, CANNOT TOGGLE BETWEEN 2D AND 3D (TWO-DIMENTIONAL/THREE DIMENTIONAL MOTION IMAGES). BY USING THE BUTTON ON THE FRONT OF THE 3DV-190 (SUBJECT DEVICE). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905755 ↗
• MalfunctionApr 12, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED TO OLYMPUS THERE WAS NO POWER WHEN TURNING ON THE 3D VISUALIZATION UNIT DURING PREPARATION FOR USE. THERE WAS NO ADDITIONAL MEDICAL TREATMENT OR SURGICAL INTERVENTION REQUIRED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728543 ↗
• MalfunctionApr 6, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE COMPANY REPRESENTATIVE ON BEHALF OF THE CUSTOMER REPORTED TO OLYMPUS THAT THEY WERE NOT ABLE TO TOGGLE TO THREE-DIMENSIONAL (3D) VISUALIZATION IMAGE USING THE 3D VISUALIZATION UNIT. THE TWO-DIMENSIONAL IMAGE WAS HOWEVER DISPLAYED. THE 3D TOGGLE BUTTONS ON THE FRONT WERE NOT LIT UP. THE CUSTOMER SWAPPED OUT THE ENDOEYE SCOPE AND THE 3D DISPLAY RETURNED. THE DIAGNOSTIC PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691150 ↗
• MalfunctionApr 3, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING PREPARATION FOR USE THE DEVICE THE 2D/3D INDICATOR LIGHT ON THE PANEL DID NOT LIGHT UP. ONLY 2D IMAGES WERE AVAILABLE. THE IMAGE WERE DISCOLORED AND YELLOWISH IN APPEARANCE. THERE IS NO PATIENT INVOLVEMENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668645 ↗
• MalfunctionJan 6, 2023No Display/Image; No Display/Image

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE ON/OFF SWITCH LED LIGHT, AROUND THE BUTTON, WAS GLOWING BUT THE 3D VISUALIZATION UNIT FRONT PANEL WAS NOT FUNCTIONING AND THE IMAGE WAS UNABLE TO DISPLAY PRIOR TO USE IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117462 ↗