Olympus WA53000ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 10 mm, 0°, HD, quick lock, autoclavable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus rigid telescope is used in laparoscopy for general and plastic surgery. The 70 reports mostly describe damage found during inspection or evaluation: cracked or chipped glass at the tip, blurry images, missing rings or glass pieces, and threads tearing off so the scope no longer fits the light cable. No deaths and no injuries were reported, and no recalls name this device. Reports fell from 17 in the earlier 12 months to 6 in the most recent 12 months.
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
- 70
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 04042761052757), received between Dec 2, 2022 and May 6, 2026 — classified as 70 malfunctions.
The most frequently reported specific device problem is “Break” (35 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
- Break35
- Detachment of Device or Device Component15
- Component Missing4
- Loose or Intermittent Connection2
- Material Fragmentation2
- Material Integrity Problem2
- Material Separation2
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions70
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Material Fragmentation
IT WAS OBSERVED THAT, DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE COVER GLASS AT THE DISTAL END WAS FOUND TO BE CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25105081 ↗MalfunctionApr 23, 2026Poor Quality Image
IT WAS REPORTED THE RIGID OPTICAL LAPAROSCOPE HAD BLURRY IMAGE. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965657 ↗MalfunctionApr 21, 2026Break
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE RIGID OPTICAL LAPAROSCOPE HAD A CHIPPED DISTAL OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948485 ↗MalfunctionFeb 9, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300404 ↗MalfunctionJan 12, 2026Component Missing
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE WAS MISSING A RING. THIS ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037060 ↗MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD A MISSING GLASS COMPONENT ON THE CABLE CONNECTION SIDE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23686871 ↗MalfunctionOct 28, 2025Component Missing; Component Missing
NO OTHER UPDATED INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405375 ↗MalfunctionAug 15, 2025Damaged Thread; Damaged Thread
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD TORN OFF THREAD AND THEREFORE IT COULD NOT FIT THE LIGHT GUIDE CABLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22814478 ↗MalfunctionAug 14, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804344 ↗MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID SCOPE HAD LENSES CAME OFF. THE ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803497 ↗MalfunctionAug 5, 2025Break; Scratched Material; Break; Scratched Material
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715696 ↗MalfunctionJul 7, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412353 ↗MalfunctionJun 3, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BROKEN BONNET/EYE PIECE FUNNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22131328 ↗MalfunctionMay 8, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN GLASS BAR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21983895 ↗MalfunctionApr 25, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE SUBJECT DEVICE'S CAP CAME OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907988 ↗MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE HAS A LOOSE COMPONENT. THIS ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902615 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT DURING REPROCESSING THE SUBJECT DEVICE HAD BROKEN BLACK RING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21756637 ↗MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TELESCOPE'S OPTICS TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634306 ↗MalfunctionFeb 21, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN EYEPIECE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432152 ↗MalfunctionJan 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A LENS THAT CAME OFF. THE ISSUE WAS IDENTIFIED DURING THE SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21141432 ↗MalfunctionDec 26, 2024Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BROKEN INNER SHEATH. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020700 ↗MalfunctionDec 12, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914684 ↗MalfunctionDec 6, 2024Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864083 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THE RIGID OPTICAL LAPAROSCOPE HAD BROKEN PARTS. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20277498 ↗MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A MISSING CAP WHERE THE LIGHT SOURCE CONNECTS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268494 ↗
Other Laparoscope, General & Plastic Surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 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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