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

Model Number	WA2T43WA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection confirmed the customer¿s reported issue, damaged components inside the optical system have been identified.The inspection also noted deformation of the rigid outer tube attributing to fiber breakage.The device was last service via repair on august 18, 2020.The cause of the damaged optical system cannot be determined at this time because the investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Event or Problem Description
Olympus (oekg) was informed via repair request that the customer oes elite, high-definition autoclavable rigid telescope has a broken component defect, ¿broken optics¿.The customer reported problem was found at an unspecified event.No death or injury and no impact to patient or other has been reported to olympus.
Event or Problem Description
It was further reported that the ¿split optics¿ issue was found during a diagnostic urology procedure.The intended procedure was completed without delay using other equipment.No device fragment fell into the patient.No impact or complications were reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional details for the event description.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE
• Common Device Name: AUTOCLAVABLE RIGID TELESCOPE
• 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: 16244200
• Report Number: 9610773-2023-00345
• Device Sequence Number: 17772976
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• 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: 01/01/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 04/13/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/27/2023; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2017
• 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