Olympus WA50042ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Video telescope "ENDOEYE HD II", 10 mm, 30°, autoclavable · Class 2
Data updated Oct 16, 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 ENDOEYE HD II video telescope is a laparoscope used in gynecologic surgery. The reports often describe poor image quality, a missing or flickering display, and breaks in the scope. FDA records list 6,045 reports, no deaths, 11 injuries and 6,034 malfunctions. There is 1 open recall, which began in November 2023 and concerns pink or green tinting of the image, which could mean swapping devices during surgery and possibly causing bleeding or tissue injury.
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
- 6,135
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6,135 adverse event reports that list this exact device (DI 04042761074971), received between Sep 24, 2018 and Sep 30, 2026 — classified as 12 injuries, 6,123 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (2,815 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 16, 2026.
Reports received per month
Recalls naming this device
- Nov 6, 2023Open, Classified
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
Z-0697-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Poor Quality Image2,815
- Communication or Transmission Problem688
- No Display/Image673
- Break587
- Optical Discoloration378
- Erratic or Intermittent Display337
- Fracture236
- Dent in Material193
Patient problems
- No Clinical Signs, Symptoms or Conditions6,112
- Insufficient Information25
- Arrhythmia1
- Hemoptysis1
- No Known Impact Or Consequence To Patient1
- Respiratory Tract Infection1
Recent adverse event reports
The 25 most recent of 6,135 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955058 ↗MalfunctionSep 30, 2026Poor Quality Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954687 ↗MalfunctionSep 30, 2026Poor Quality Image; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953656 ↗MalfunctionSep 30, 2026Break; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953456 ↗MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952858 ↗MalfunctionSep 30, 2026Poor Quality Image; Material Deformation; Optical Discoloration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952205 ↗MalfunctionSep 30, 2026Fracture; Optical Discoloration
It was reported that during an unknown procedure with use of the gynecologic laparoscope, the viewable image developed a green tint/discoloration on the screen. The device was replaced with a back-up device and the procedure was completed. During the initial evaluation of the device, it was observed that the fibre bonding in the outer tube area (distal end) is damaged and the video cable is broken (which resulted in the green image.)No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950835 ↗MalfunctionSep 30, 2026Erratic or Intermittent Display; Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950027 ↗MalfunctionSep 30, 2026No Display/Image; Display or Visual Feedback Problem
It was reported that during a diagnostic procedure, the videoscope's monitor displayed a black screen. The customer also reported that the image suddenly shifted entirely to green tones, and they had to replace the scope. There were no reports of any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949673 ↗MalfunctionSep 30, 2026Fracture; Poor Quality Image
The customer reported purple stripes in the image during inspection for use. During the initial evaluation of the device, it was observed that the fiber bonding in the outer tube area (distal end) was damaged. involving an Olympus gynecologic laparoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949262 ↗MalfunctionSep 30, 2026Poor Quality Image; Material Integrity Problem
The customer reported that the image appears green involving an Olympus Laparoscope, Gynecologic. Additionally, during the initial evaluation of the device, damaged fibre bonding in the outer tube area was observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948591 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947890 ↗MalfunctionSep 30, 2026Degraded; Fracture
The customer returned the Olympus Laparoscope Gynecologic for a separate issue. During the initial evaluation of the returned device, protector of the video cable section is overstressed and the fiber bonding in the outer tube area (distal end) is damaged observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947849 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
It was reported that during an unspecified therapeutic procedure, the gynecologic laparoscope experienced a B-31 error code. The reported event resulted in a procedural prolongation of less than 30 minutes. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947557 ↗MalfunctionSep 30, 2026No Display/Image; Poor Quality Image
It was reported that at the start of an unknown procedure using the gynecologic laparoscope, green and purple lines were seen at the top of the screen. The customer reported that they restarted the device after a short time, the lines reappeared then the screen went black. Another restart was performed without image problems, and the procedure was completed. There was no report of patient harm or adverse patient event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947207 ↗MalfunctionSep 30, 2026Crack; Poor Quality Image
The customer reported poor image quality involving an Olympus Laparoscope, Gynecologic. Additionally, during the initial evaluation of the device, a green image and a cracked cover glass in the Insertion section were observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944764 ↗MalfunctionSep 29, 2026Break; Dent in Material; Material Integrity Problem; Optical Problem; Sharp Edges
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938659 ↗MalfunctionSep 29, 2026Break; Erratic or Intermittent Display; No Display/Image; Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934233 ↗MalfunctionSep 29, 2026Break; Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934012 ↗MalfunctionSep 29, 2026Crack; Poor Quality Image
The customer reported that the image looked green involving an Olympus Laparoscope. During initial evaluation, cracked coverglass of the insertion section was observed. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933050 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924219 ↗MalfunctionSep 28, 2026Break; Degraded; Erratic or Intermittent Display
The customer reported image discoloration during an unspecified procedure involving an Olympus Laparoscope, Gynecologic, which was completed with the same device. Additionally, during the initial evaluation of the device, a broken Charge Coupled Device unit, distal end of the insertion section with contour sharpness, and a green image were observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920327 ↗MalfunctionSep 28, 2026Break; Erratic or Intermittent Display; Electrical /Electronic Property Problem; Fracture; Communication or Transmission Problem
The customer reported the Olympus Gynecologic Laparoscope had an Error E226 during an unspecified procedure. During the initial evaluation of the device it was observed, the fiber bonding in the outer tube area is damaged, the Charged Coupled Device is broken, the dielectric strength is inadequate and stripes in image occur were observed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917926 ↗MalfunctionSep 28, 2026Leak/Splash; Failure to Clean Adequately
The customer returned the Gynecologic Laparoscope¿to the service center for evaluation related to a separate issue. During testing, the service repair technician identified dirt on the grip and water leakage in the device. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917237 ↗MalfunctionSep 28, 2026No Display/Image; Communication or Transmission Problem
It was reported that during an unspecified therapeutic procedure, the Rigid Video Scope displayed the error "Fog Free function has been disabled" after being placed in a scope warmer, during which the scope image went black. The fog-free function subsequently remained nonfunctional. The procedure was completed using a backup device with no reports of further patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916598 ↗
Other Laparoscope, Gynecologic (And Accessories) devices
- Olympus WA50052AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)2,249 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5Olympus Medical Systems Corp. · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall1,279 reports
- Olympus WA50040AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall954 reports
- Olympus WA50050AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)895 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5Olympus Medical Systems Corp. · Laparoscope, Gynecologic (And Accessories)624 reports
- Epix Laparoscopic Scissors CB030Applied Medical Resources Corporation · Laparoscope, Gynecologic (And Accessories)239 reports
- HD EndoEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VHOlympus Medical Systems Corp. · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)168 reports
- AHTO 0250070620Stryker Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)2 recalls59 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page