Olympus WA53005ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 10 mm, 30°, HD, quick lock, autoclavable · Class 2
Quick summary
This Olympus rigid laparoscope has 222 adverse event reports: 221 describe malfunctions and 1 describes an injury, with no deaths. Many reports describe chipped or cracked lenses and glass, parts coming loose or detaching, and damage found during service checks. Nearly all reports record no effect on the patient. 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
- 224
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 224 adverse event reports that list this exact device (DI 04042761052764), received between Jun 4, 2019 and Sep 1, 2026 — classified as 1 injury, 223 malfunctions.
The most frequently reported specific device problem is “Break” (114 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
- Break114
- Detachment of Device or Device Component51
- Crack14
- Loose or Intermittent Connection11
- Component Missing9
- Poor Quality Image7
- Mechanical Problem6
- Material Integrity Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 224 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551544 ↗MalfunctionAug 19, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330315 ↗MalfunctionAug 10, 2026Break
The customer returned the rigid optical laparoscope to the service center for a separate issue. During device analysis, the service repair technician identified damage to the tip cover glass, with resulting glass fragments causing reflections in the image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190336 ↗MalfunctionApr 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THE RIGID OPTICAL LAPAROSCOPE EXPERIENCED BLACK ISLAND COVER WAS DETACHED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982591 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED A CHIPPED LIGHT GUIDE LENS AT THE DISTAL END, MISSING PART OF LIGHT GUIDE SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24870086 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714400 ↗MalfunctionMar 24, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED EXTREMELY WORN DISTAL TERMINAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680408 ↗MalfunctionMar 11, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD BROKEN WINDSCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566481 ↗MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD A DETACHED ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468554 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457555 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD A DETACHED EYEPIECE FUNNEL. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428935 ↗MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE WAS BROKEN. THE ISSUE WAS FOUND DURING A REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414598 ↗MalfunctionFeb 20, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD MISSING EYE PIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405433 ↗MalfunctionFeb 19, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CRACK AT EYEPIECE FUNNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387357 ↗MalfunctionFeb 17, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD LOOSE ADHESIVE CONNECTION OF THE LIGHT GUIDE POST WHICH LED TO DETACHMENT OF THE POST. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364856 ↗MalfunctionFeb 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD LOOSE EYEPIECE. 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 24333214 ↗MalfunctionFeb 11, 2026Component Missing
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD EXHIBITED THAT PARTS OF THE LIGHT GUIDE SECTION WERE MISSING, ALONG WITH A COMPONENT FAILURE OF THE LIGHT GUIDE BUNDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318058 ↗MalfunctionFeb 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED DETACHED FUNNEL CUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278391 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD THE BLACK PLASTIC EYE PIECE SNAPPED OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210906 ↗MalfunctionJan 27, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189743 ↗MalfunctionJan 16, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD A DETACHED ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24098878 ↗MalfunctionJan 12, 2026Break; Mechanical Problem
DURING DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE WAS FOUND TO HAVE BROKEN CONNECTIONS AND LOOSE PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24049869 ↗MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD A BROKEN BLACK HEAD FROM THE VIEWING SIDE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027382 ↗MalfunctionDec 23, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED SOME LIGHT GUIDE FIBERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879388 ↗MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID SCOPE HAD EYEPIECE CAME OFF. THE ISSUE WAS FOUND DURING AN INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767516 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.