MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE; RIGID ARTHROSCOPE

Model Number	A70941A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Based on the results of the investigation a root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed during the device evaluation that the rigid arthroscope exhibited a detached eyepiece funnel.There was no patient involvement.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
• Common Device Name: RIGID ARTHROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23897662
• Report Number: 9610773-2025-08497
• Device Sequence Number: 18671186
• Product Code: HRX
• UDI-Device Identifier: 04042761010542
• UDI-Public: 04042761010542
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: A70941A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown