Olympus A70963ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "TrueView II", 2.7mm, 30°, short, autoclavable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761010658), received between Jul 17, 2023 and Feb 23, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Detachment of Device or Device Component1
- Fracture1
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD MISSING EYE PIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413491 ↗MalfunctionJul 25, 2025Fracture; Optical Problem; Fracture; Optical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED A BREAKAGE ON OBJECTIVE COVER GLASS, INSERTION TUBE BROKEN AND LIGHT GUIDE FIBER BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610569 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT THE LENS OF THE SUBJECT DEVICE WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446158 ↗MalfunctionJul 1, 2024Break; Break
IT WAS REPORTED THE AUTOCLAVABLE TELESCOPE HAD A BREAK IN THE TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19645433 ↗MalfunctionNov 29, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE "TRUEVIEW II", 2.7MM, 30°, SHORT, AUTOCLAVABLE HAD BROKEN INTO TWO PIECES. THE EVENT OCCURRED DURING STERILIZATION. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18228899 ↗MalfunctionSep 28, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "TRUEVIEW II" HAD A BROKEN LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17831370 ↗MalfunctionJul 21, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE LENS OF THE SCOPE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17368523 ↗MalfunctionJul 17, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "TRUEVIEW II" HAD A BROKEN LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17334235 ↗
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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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