Olympus A70961ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "TrueView II", 2.7 mm, 30°, autoclavable · Class 2
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04042761010634), received between Dec 16, 2022 and Feb 27, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Detachment of Device or Device Component5
- Thermal Decomposition of Device2
- Fracture1
- Material Twisted/Bent1
- Pitted1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED TIP COVER GLASS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468883 ↗MalfunctionFeb 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE WAS RECEIVED WITHOUT INNER OUTER ADAPTERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24412131 ↗MalfunctionFeb 17, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD A LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365439 ↗MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THAT THE RIGID ARTHROSCOPE HAD FRACTURE ON THE SHAFT DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24021180 ↗MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED NO INNER/OUTER ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816542 ↗MalfunctionDec 12, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789364 ↗MalfunctionDec 3, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OUTER TUBE OF THE RIGID ARTHROSCOPE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707517 ↗MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED FUNNEL MISSING OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23553092 ↗MalfunctionAug 14, 2025Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD DISTAL THERMAL DAMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809804 ↗MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE BLACK EYE COUPLER CAME OFF. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE, BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778070 ↗MalfunctionJun 4, 2025Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISTAL END OF INSERTION TUBE FOUND TO BE BURNT AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140580 ↗MalfunctionMay 29, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105523 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THE RIGID ARTHROSCOPE TIP WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537695 ↗MalfunctionSep 6, 2024Pitted; Pitted
THE ISSUE OCCURRED DURING INSPECTION FOR USE FOR A THERAPEUTIC PROCEDURE THAT WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20160856 ↗MalfunctionAug 14, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED A BROKEN OPTICAL LENS, BENT OUTER TUBE, AND NON-OLYMPUS OUTER ADAPTER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983278 ↗MalfunctionMay 13, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE "TRUEVIEW II", 2.7 MM, 30°, AUTOCLAVABLE DISPLAYED A BROKEN TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19297375 ↗MalfunctionApr 11, 2024Break; Break
IT WAS REPORTED THE RIGID ARTHROSCOPE'S TIP WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19087392 ↗MalfunctionMar 27, 2023Break; Break
COMPANY REPRESENTATIVE REPORTED THE DEVICE INSERTION TUBE WAS SNAPPED IN HALF, A SERVICE REPAIR ORDER WAS REQUESTED. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16617048 ↗MalfunctionDec 28, 2022Scratched Material; Scratched Material
THE CUSTOMER REPORTED THERE WAS DUST IN THE IMAGE OF THE AUTOCLAVABLE TRUEVIEW II TELESCOPE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE COMPLAINT WAS CONFIRMED AND THE COVER GLASS WAS SCRATCHED. THE REPORT IS BEING SUBMITTED DUE TO THE SCRATCHED COVER GLASS FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16060377 ↗MalfunctionDec 16, 2022Break; Break
OLYMPUS WAS INFORMED THAT THE CUSTOMER TRUEVIEW II AUTOCLAVABLE TELESCOPE HAS A REPORTED DEFECTIVE FIBER, ¿REFIBER NEEDED¿. THE CUSTOMER REPORTED IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO DEATH INJURY OR INFECTION AND NO PERSON OR OTHER WAS AFFECTED WAS REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000490 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.