MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE; URETHROSCOPE

Model Number	WA2T43WA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus that a telescope resectoscope had a blurry image.The reportable event was found during estimation of the device.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The device has not been 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.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.During their inspection, the service department confirmed the issue reported by the customer and identified the following: blurry image.Damaged parts in the optical system.Deformation of the outer tube.Fiber breakage.The identified fault patterns are most likely attributable to the use of excessive force by the customer.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE
• Common Device Name: URETHROSCOPE
• 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: 16189618
• Report Number: 9610773-2023-00247
• Device Sequence Number: 5794906
• Product Code: FGC
• UDI-Device Identifier: 04042761077569
• UDI-Public: 04042761077569
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151191
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: WA2T43WA
• Device Catalogue Number: WA2T43WA
• 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: 12/18/2022
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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