MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 30°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE; RIGID RHINOSCOPE

Model Number	WA96201A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus. the investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, the olympus autoclavable telescope, had broken/damaged fibers.The event was found during reprocessing.No death, injury or harm to patient or other has been reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the damaged fibers could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 4 MM, 30°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: RIGID RHINOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16457466
• Report Number: 9610773-2023-00609
• Device Sequence Number: 12405350
• Product Code: EOB
• UDI-Device Identifier: 04042761070034
• UDI-Public: 04042761070034
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: WA96201A
• Device Catalogue Number: WA96201A
• Device Lot Number: 747283
• Was Device Available for Evaluation?: Yes
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• 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