Olympus WA4KL100Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 10 mm, 0° · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus rigid video laparoscope is a surgical telescope. The 39 reports mostly describe the scope breaking or cracking — tips, light posts and internal lenses coming loose, detaching or going missing — along with a few poor image and burned tip reports. One injury was reported and no deaths. There are no recalls naming 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
- 39
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04042761082846), received between Jun 26, 2019 and May 4, 2026 — classified as 1 injury, 38 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break21
- Detachment of Device or Device Component7
- Crack3
- Component Missing2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Dent in Material1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Burn, Thermal1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073669 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED DETACHMENT OF THE INTERNAL LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664585 ↗MalfunctionFeb 17, 2026Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367705 ↗MalfunctionFeb 16, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD A LOOSE LENS MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345370 ↗MalfunctionFeb 6, 2026Overheating of Device
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A BURNED TIP DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR¿S DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280542 ↗MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A BROKEN LIGHT POST. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277896 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A DAMAGED PART CONNECTED TO THE CAMERA. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209094 ↗MalfunctionDec 23, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED LENS INSIDE THE OPTICAL SYSTEM IS BROKEN. / DISTAL END LENS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877742 ↗MalfunctionDec 17, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830063 ↗MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23806453 ↗MalfunctionNov 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523916 ↗MalfunctionOct 16, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD BROKEN LIGHT EMITTING SURFACE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316776 ↗MalfunctionJun 25, 2025Crack; Crack
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BLACK SPLIT HOOD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331856 ↗MalfunctionApr 29, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927810 ↗MalfunctionApr 18, 2025Break; Break
IT WAS REPORTED THAT THE RIGID SCOPE HAD BROKEN LIGHT POST. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21868874 ↗MalfunctionFeb 19, 2025Melted; Melted
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411945 ↗MalfunctionFeb 3, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21293729 ↗MalfunctionOct 4, 2024Break; Break
IT WAS REPORTED THE TELESCOPE HAD A BROKEN LENS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20375545 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE "ULTRA", 10 MM, 0° EXHIBITED A BROKEN COMPONENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20277704 ↗MalfunctionJul 5, 2024Break; Break
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19678825 ↗MalfunctionJul 3, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE WAS MISSING AN ADAPTER PIECE FROM THE LIGHT ATTACHMENT. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667758 ↗MalfunctionApr 25, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE'S LIGHT GUIDE CONNECTER WAS DAMAGED. THE ISSUE OCCURRED, DURING CLEAN UP AFTER A THERAPEUTIC SURGERY. THERE WERE NO REPORTS OF PATIENT HARM, NO DELAY. AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. AS THE MALFUNCTION OCCURRED, AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181766 ↗MalfunctionFeb 25, 2024Break; Break
IT WAS REPORTED THAT THE TELESCOPE "ULTRA", 10 MM, 0° HAD A BROKEN PIECE THAT YOU LOOK THROUGH. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18774837 ↗MalfunctionDec 18, 2023Defective Component; Defective Component
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE HAD A BAD FIBER OPTIC LIGHT CORD. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18345079 ↗MalfunctionDec 13, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE "ULTRA", 10 MM, 0° HAD NO BLURRY IMAGE, ONLY A FEW FIBERS WERE BROKEN. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317197 ↗
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
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page