Olympus WA50050ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Video telescope "ENDOEYE HD II", 5.4 mm, 0°, autoclavable · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ENDOEYE HD II video telescope appears in 876 adverse event reports, with 3 injuries and no deaths. Many describe poor image quality, fiber breaks, and dents and cracks in its parts, with some mentioning stains and black marks on the connector. Reports in the last year rose to 395, from 259 in the year before. No recalls name this device.
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
- 895
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 895 adverse event reports that list this exact device (DI 04042761075008), received between Dec 16, 2020 and Sep 30, 2026 — classified as 3 injuries, 892 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (262 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 Image262
- Break182
- Dent in Material139
- No Display/Image119
- Crack98
- Material Twisted/Bent80
- Scratched Material68
- Loose or Intermittent Connection49
Patient problems
- No Clinical Signs, Symptoms or Conditions892
- Insufficient Information2
- Burn(s)1
Recent adverse event reports
The 25 most recent of 895 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Contamination; No Display/Image
The customer reported the Olympus rigid video laparoscope can see through it during an unspecified procedure. During the initial evaluation of the device, it was observed, Fiber breakage, Brown stains under light guide cover glass and absolutely no image. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944571 ↗MalfunctionSep 29, 2026Break; Loose or Intermittent Connection; Poor Quality Image
The customer reported camera picture was not clear involving an Olympus rigid video laparoscope. During initial evaluation it was observed, distal fiber breakage and loose adapter. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936635 ↗MalfunctionSep 29, 2026Break; Crack; Low Readings; Moisture or Humidity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926868 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916068 ↗MalfunctionSep 28, 2026Leak/Splash
The customer reported a leak during an inspection for use involving an Olympus rigid video laparoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915848 ↗MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889774 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
The customer returned the rigid video laparoscope for a separate issue. During the initial evaluation of the device, it was observed, distal fibers and fiber breakage was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884032 ↗MalfunctionSep 24, 2026Material Discolored
The customer returned the rigid video laparoscope for a separate issue. During the initial evaluation of the returned device, minor stains and minor brown spots under the light guide cover glass were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876742 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874148 ↗MalfunctionSep 23, 2026Leak/Splash
The customer reported that leakage occurred during inspection for use involving an Olympus Rigid Video Laparoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872041 ↗MalfunctionSep 23, 2026Crack; Poor Quality Image
The customer reported Cracked Lens during inspection for use, Involving an Olympus rigid video Laparoscope. During the initial device evaluation, a cracked image was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863155 ↗MalfunctionSep 23, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862990 ↗MalfunctionSep 22, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861743 ↗MalfunctionSep 16, 2026Break; Detachment of Device or Device Component
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, a chipped light guide bundle and damaged distal end was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782524 ↗MalfunctionSep 15, 2026No Display/Image; Communication or Transmission Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765976 ↗MalfunctionSep 14, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765793 ↗MalfunctionSep 14, 2026Break; Poor Quality Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765743 ↗MalfunctionSep 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747944 ↗MalfunctionSep 12, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744695 ↗MalfunctionSep 11, 2026No Display/Image; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740725 ↗MalfunctionSep 11, 2026Break; No Display/Image; Loose or Intermittent Connection; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725265 ↗MalfunctionSep 10, 2026Break; Loose or Intermittent Connection; Poor Quality Image; No Device Output
The customer returned the rigid video laparoscope for a separate issue. During the initial evaluation of the returned device, Fiber breakage, Loose adapter, Out of direction on image and Light Transmission failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714188 ↗MalfunctionSep 9, 2026Break; Poor Quality Image; Connection Problem; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702516 ↗MalfunctionSep 6, 2026Material Twisted/Bent; Optical Discoloration; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50640744 ↗MalfunctionSep 6, 2026Break; Poor Quality Image; Dent in Material; Material Twisted/Bent; Optical Discoloration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50639821 ↗
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 WA50040AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall954 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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