Olympus WA50052ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Video telescope "ENDOEYE HD II", 5.4 mm, 30°, autoclavable · Class 2
Quick summary
This Olympus ENDOEYE HD II video laparoscope has 2,201 reports, with no deaths and 2 injuries. Many describe poor image quality, parts breaking, no image on the display, or dents in the scope. No recalls name this device. Reports rose to 1,027 in the last 12 months from 670 in the previous 12.
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
- 2,249
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,249 adverse event reports that list this exact device (DI 04042761075015), received between Jan 23, 2023 and Sep 30, 2026 — classified as 2 injuries, 2,247 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (798 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
- Poor Quality Image798
- Break368
- No Display/Image309
- Dent in Material259
- Communication or Transmission Problem129
- Material Twisted/Bent125
- Scratched Material110
- Erratic or Intermittent Display109
Patient problems
- No Clinical Signs, Symptoms or Conditions2,245
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 2,249 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954832 ↗MalfunctionSep 30, 2026Contamination; Loose or Intermittent Connection; Output Problem
The customer reported that the rigid video laparoscope had a separate issue. During the initial evaluation of the returned device, dust particles under the distal cover glass, a loose outer tube, and low light transmission were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951766 ↗MalfunctionSep 30, 2026Break; No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949921 ↗MalfunctionSep 30, 2026Poor Quality Image
The customer reported that the rigid video laparoscope had a very blurry image from the optics. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949373 ↗MalfunctionSep 30, 2026Break; Incomplete or Inadequate Connection
The customer reported that the rigid video laparoscope had only half of the connector at the tip was unscrewed during reprocessing. During the initial evaluation of the device, it was observed fiber bonding in the outer tube area (distal end); the laser light cable (LLK) plug of the video cable section was damaged. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949032 ↗MalfunctionSep 29, 2026Break; Poor Quality Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938815 ↗MalfunctionSep 29, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935725 ↗MalfunctionSep 29, 2026Poor Quality Image
The customer reported a black circle on the screen when the device was plugged in during an inspection for use involving an Olympus rigid video laparoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934590 ↗MalfunctionSep 29, 2026Fracture; Material Deformation
The customer reported the rigid video laparoscope had kink in the optics during reprocessing. During the initial evaluation of the device it was observed, fiber bonding in the outer tube area (distal end) is damaged and charged coupled device (R-Unit) has a kink noted or observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934514 ↗MalfunctionSep 29, 2026Break; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934481 ↗MalfunctionSep 29, 2026Image Orientation Incorrect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934129 ↗MalfunctionSep 29, 2026Crack; Loose or Intermittent Connection; Moisture Damage; Poor Quality Image; Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934024 ↗MalfunctionSep 28, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924559 ↗MalfunctionSep 28, 2026Break; Detachment of Device or Device Component
The customer returned the rigid video laparoscope for a separate issue. During the initial evaluation of the device, it was observed that there was minor fiber breakage and loose adapter. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918283 ↗MalfunctionSep 28, 2026No Display/Image; Dent in Material; Scratched Material
The customer reported the rigid video laparoscope image went out during an inspection for use. During the initial evaluation of the device, dents and scratches were observed on the distal end. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914699 ↗MalfunctionSep 24, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891337 ↗MalfunctionSep 24, 2026Break; Loose or Intermittent Connection; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890039 ↗MalfunctionSep 24, 2026Poor Quality Image; Positioning Problem
It was reported that the video telescope produced a good image when viewed up close; however, when panned out, the image quality deteriorated. In addition, the angle adjustment on the main body twisted to the right side and was reported to be very loose. The issue occurred during a therapeutic procedure was delayed for less than 30 minutes under sedation and was completed using an Olympus backup device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886486 ↗MalfunctionSep 23, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875917 ↗MalfunctionSep 23, 2026Crack; Poor Quality Image; Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873988 ↗MalfunctionSep 23, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873735 ↗MalfunctionSep 23, 2026Poor Quality Image
The customer reported the rigid video laparoscope had a blurry image during inspection for use. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873008 ↗MalfunctionSep 23, 2026Break
During onsite inspection of rigid video laparoscope, it was found that chipped light guide bundle. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869985 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer reported an error E216 during inspection for use involving an Olympus rigid video laparoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869702 ↗MalfunctionSep 23, 2026Break; Contamination; Poor Quality Image; Dent in Material; Output Problem; Scratched Material
The customer reported the rigid video laparoscope had a green image during reprocessing. During the initial evaluation of the device, fiber breakage, minor scratches on the frame, dents and scratches on the outer tube, failed light transmission, and minor stains under the light guide cover glass were observed. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868545 ↗
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- Olympus WA50050AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)895 reports
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- AHTO 0250070620Stryker Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)2 recalls59 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.