MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE; RIGID RHINOSCOPE

Model Number	WA96200A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), as well as a historical trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, and the condition of the subject device, it is believed that the reported failure was the result of improper handling and an application of excessive force.An impact or fall of the eyepiece could lead to damaged interior components, causing something to become stuck in the eyepiece window.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the telescope's tip was broken.The issue occurred during a therapeutic procedure.There were no reports of patient harm and the intended procedure was able to be successfully completed with a similar device.

• Brand Name: TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: RIGID RHINOSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19450965
• Report Number: 9610773-2024-01365
• Device Sequence Number: 7107033
• Product Code: EOB
• UDI-Device Identifier: 04042761070027
• UDI-Public: 04042761070027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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: WA96200A
• Device Lot Number: 724226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2016
• 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