Olympus WA4KL130Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 10 mm, 30° · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ULTRA telescope, a rigid laparoscope used to view inside the body during gynecologic surgery, has 116 adverse event reports on file. Many describe lenses detaching, chipping or breaking, often found during device evaluation with no patient involved. The reports include no deaths and no injuries, and 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
- 117
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 04042761082853), received between Dec 1, 2022 and Sep 8, 2026 — classified as 117 malfunctions.
The most frequently reported specific device problem is “Break” (46 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
- Break46
- Detachment of Device or Device Component29
- Loose or Intermittent Connection10
- Crack7
- Mechanical Problem7
- Poor Quality Image6
- Component Missing5
- Material Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672749 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253905 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING DEVICE EVALUATION, THE MENISCUS OF RIGID OPTICAL TELESCOPE WAS LOOSEN APART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25084877 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED DETACHED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056584 ↗MalfunctionApr 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052602 ↗MalfunctionMar 24, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD MENISCUS CHIPPED OF OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680563 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD DETACHED DISTAL END LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661231 ↗MalfunctionMar 23, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED DETACHED AND BROKEN LENS AT DISTAL TERMINAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660234 ↗MalfunctionMar 19, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED DETACHED AND DAMAGED DISTAL END LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637402 ↗MalfunctionMar 3, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498110 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THE RIGID OPTICAL LAPAROSCOPE HAS LOST THE LIGHT GUIDE ADAPTER DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484693 ↗MalfunctionFeb 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED IMAGE BUNDLE WAS SEPARATED FROM BUNDLE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421205 ↗MalfunctionFeb 19, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD LOOSE BLUE RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24393164 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
NO NEW ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389690 ↗MalfunctionFeb 19, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CRACKED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389527 ↗MalfunctionFeb 16, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE PRESENTED TIP COVER GLASS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343512 ↗MalfunctionFeb 4, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID TELESCOPE EXHIBITED DAMAGED OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259231 ↗MalfunctionJan 28, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202668 ↗MalfunctionJan 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD THE EYEPIECE CUP COME OFF. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161777 ↗MalfunctionJan 15, 2026Detachment of Device or Device Component
NO OTHER ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24078971 ↗MalfunctionDec 30, 2025Unstable; Unstable
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED LIGHT GUIDE (LG)-ROD WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923829 ↗MalfunctionDec 10, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT RIGID OPTICAL LAPAROSCOPE HAD LOOSE EYEPIECE. THE ISSUE WAS IDENTIFIED DURING A VIDEO-ASSISTED THORACOSCOPIC THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767049 ↗MalfunctionDec 4, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM COSTUMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715108 ↗MalfunctionNov 12, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533988 ↗MalfunctionAug 28, 2025Crack; Material Rupture; Crack; Material Rupture
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FRACTURED THE WIRE OF LIGHT GUIDE BUNDLE, AND THE CRACKED LENS AT DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22913506 ↗
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.
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