Olympus WA50040ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Video telescope "ENDOEYE HD II", 10 mm, 0°, 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 laparoscope is a camera used during keyhole surgery. The 942 reports mostly describe poor image quality, transmission problems, a blank display and breakage. One report describes a full-thickness burn. The reports include no deaths and 4 injuries. There is 1 recall, open, started November 2023, about pink or green image tints, which could mean swapping devices mid-surgery and potential tissue injury or bleeding.
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
- 954
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 954 adverse event reports that list this exact device (DI 04042761074964), received between Dec 9, 2022 and Sep 30, 2026 — classified as 4 injuries, 950 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (406 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 Image406
- Communication or Transmission Problem131
- No Display/Image105
- Break103
- Optical Discoloration42
- Fracture36
- Dent in Material35
- Erratic or Intermittent Display34
Patient problems
- No Clinical Signs, Symptoms or Conditions952
- Full thickness (Third Degree) Burn1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 954 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 50953875 ↗MalfunctionSep 30, 2026Break; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953229 ↗MalfunctionSep 29, 2026Poor Quality Image
The customer reported a green image involving an Olympus rigid video laparoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935097 ↗MalfunctionSep 28, 2026Poor Quality Image
The customer reported focus image issue during laparoscopic cholecystectomy therapeutic procedure that was completed with an Olympus back-up device involving an Olympus rigid video laparoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914573 ↗MalfunctionSep 24, 2026Poor Quality Image
The customer reported the Olympus rigid video laparoscope had image interference/lines and image foggy/misty during installation. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889549 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
The customer returned the rigid video laparoscope for a separate issue. During the initial evaluation of the returned device, fiber bonding in the outer tube area (distal end) was damaged. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882954 ↗MalfunctionSep 23, 2026Break; Poor Quality Image
The customer reported the Olympus rigid video scope image became green during inspection for use. During the initial evaluation of the device, a defective light guide bundle at the distal end was observed. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872930 ↗MalfunctionSep 23, 2026No Display/Image; Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872918 ↗MalfunctionSep 23, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871482 ↗MalfunctionSep 22, 2026Poor Quality Image
The customer reported a noisy image during maintenance involving an Olympus Rigid Video Laparoscope. Additionally, during the initial evaluation of the device, multiple horizontal stripes of noise were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857290 ↗MalfunctionSep 22, 2026Crack; Poor Quality Image
The customer returned the rigid video laparoscope to the service center for a separate issue. During the device analysis, the service repair technician indicated that a light guide lens with a crack and a noisy image were found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855614 ↗MalfunctionSep 22, 2026Break; Erratic or Intermittent Display; Poor Quality Image
The customer reported the rigid video laparoscope had an abnormal image and the screen became noised during reprocessing. During the initial evaluation of the device, it was observed the light guide bundle of insertion section was slightly interrupted and weakened; the universal cord malfunctioned and the insertion beam was slightly dimmed. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853055 ↗MalfunctionSep 21, 2026Crack; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848716 ↗MalfunctionSep 21, 2026Break; Poor Quality Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847716 ↗MalfunctionSep 21, 2026Break; Display or Visual Feedback Problem
The customer reported that the rigid video laparoscope displayed image noise during therapeutic laparoscopy procedure while the patient was under sedation. The intended procedure was completed using a backup device. During the initial evaluation of the device, the fiber bonding in the outer tube area at the distal end was damaged, and no image was displayed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846453 ↗MalfunctionSep 21, 2026No Display/Image; Communication or Transmission Problem; Material Integrity Problem
The customer reported the rigid video laparoscope no image during Inspection for use. During the initial evaluation of the device it was observed, E218 (scope error) and the fiber bonding in the outer tube area (distal end) was damaged. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838912 ↗MalfunctionSep 14, 2026No Display/Image; Material Integrity Problem
The customer returned the rigid video laparoscope to the service center for a separate issue. During the device analysis, the service repair technician indicated that no image and damaged fibre bonding in the outer tube area at the distal end were found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756325 ↗MalfunctionSep 11, 2026Communication or Transmission Problem
The customer reported E104 fog free function for an Olympus rigid video laparoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734039 ↗MalfunctionSep 11, 2026Break; Crack; Poor Quality Image; Dent in Material; Scratched Material
The customer reported a broken lens during reprocessing involving an Olympus rigid video laparoscope. Additionally, during the initial evaluation of the device, a cracked objective lens, cracked light guide connector and cover glass, dents and scratches on the outer tube, and a cracked image were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733894 ↗MalfunctionSep 10, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722085 ↗MalfunctionSep 9, 2026Break; Erratic or Intermittent Display; Electrical /Electronic Property Problem; Residue After Decontamination; Communication or Transmission Problem; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692069 ↗MalfunctionSep 1, 2026Material Puncture/Hole; Optical Discoloration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534596 ↗MalfunctionAug 26, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460823 ↗MalfunctionAug 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438731 ↗MalfunctionAug 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303649 ↗
Other Laparoscope, Gynecologic (And Accessories) devices
- Olympus WA50042AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall6,135 reports
- 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 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.
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