MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE; ARTHROSCOPY SYSTEM

Model Number	A70940A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the telescope "trueview ii", 4 mm, 0°, autoclavable does not have the cold light prism.The event occurred during a therapeutic an ear, nose, throat procedure.The procedure was completed using a similar device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information including the device evaluation results and the legal manufacturer's final investigation.Additionally, no was selected for (d8) was this device serviced by a third party?, (d9) returned to manufacturer date was added, (h3) device evaluated by manufacturer was updated to yes, and (h4) device manufacturer date was added.The device was returned to olympus for evaluation and the customer's allegation was confirmed, the image was dark due to the missing component (cold light prism/light guide cone).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the cause of the missing component was determined to be consistent with device handling, impact or fall damage.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE
• Common Device Name: ARTHROSCOPY SYSTEM
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18483665
• Report Number: 9610773-2024-00135
• Device Sequence Number: 9077806
• Product Code: HRX
• UDI-Device Identifier: 04042761010535
• UDI-Public: 04042761010535
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: Health Professional
• Device Model Number: A70940A
• Device Lot Number: 800313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown