Olympus WA4KL500Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 5.4 mm, 0° · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus laparoscope has 131 reports, all malfunction reports, many describing a cracked, chipped or broken lens or optical parts. The reports mention no deaths or 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
- 131
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 04042761082877), received between Dec 2, 2022 and Jun 20, 2026 — classified as 131 malfunctions.
The most frequently reported specific device problem is “Break” (69 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break69
- Detachment of Device or Device Component18
- Crack17
- Material Twisted/Bent7
- Material Fragmentation6
- Loose or Intermittent Connection5
- Component Missing3
- Dent in Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions131
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE RIGID OPTICAL LAPAROSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, CHIPPED LENS OPTICAL SYSTEM. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570290 ↗MalfunctionJun 2, 2026Dent in Material
THE CUSTOMER RETURNED THE RIGID OPTICAL LAPAROSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD CHIPPED OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365406 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD A CHIP IN THE LENS. THE EVENT OCCURRED DURING INSPECTION FOR USE.THERE WERE NO REPORTS OF PATIENT HARM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229989 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD COMPLETELY SHATTERED LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162686 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD SHATTERED SCOPE APPEARED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162664 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD BUSTED FIBERS. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136890 ↗MalfunctionMay 1, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED AND BROKEN LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056939 ↗MalfunctionApr 24, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENSES IN THE OPTICS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24978003 ↗MalfunctionApr 22, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENSES IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956582 ↗MalfunctionApr 20, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED LENSES IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932935 ↗MalfunctionApr 15, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENS IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883589 ↗MalfunctionApr 1, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD BROKEN OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753963 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED OBJECT WINDOW CHIPPED MENISCUS LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734311 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730124 ↗MalfunctionMar 30, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE PRESENTED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24725461 ↗MalfunctionMar 30, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD A CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715233 ↗MalfunctionMar 30, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712434 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENS IN OPTICAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701331 ↗MalfunctionMar 26, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697982 ↗MalfunctionMar 19, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD MULTIPLE CHIPS ON OPTICAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637481 ↗MalfunctionMar 17, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618619 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551345 ↗MalfunctionMar 6, 2026Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID OPTICAL LAPAROSCOPE EXHIBITED BROKEN COVER GLASS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24535203 ↗MalfunctionFeb 23, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD LOOSE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421527 ↗MalfunctionFeb 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD MENISCUS LOOSEN APART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24417556 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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