MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 0°, HD, AUTOCLAVABLE; HD AUTOCLAVABLE TELESCOPE

Model Number	WA2T400A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The repair inspection confirmed the customer¿s reported defect, blurry with shadow on the image due to broken lens in the optical system.The inspection identified a broken/cracked eyepiece funnel (reportable).Additionally, the inspection noted, the rigid outer tube is bent, there is distal end fiber damage, and minor fading of the markings on the model ring.The investigation is ongoing.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 was informed that the customer ¿oes elite¿ high-definition autoclavable telescope was returned to the olympus repair center for a reported ¿blurry lens¿.The customer reported defect was found at reprocessing.No death injury or infection and no person or other was affected has been reported to olympus.However, during the repair inspection, olympus found the eyepiece funnel is cracked.This report is being submitted to capture the broken eye piece component.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely the reported issue occurred due to excessive use as well as wear and tear.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 0°, HD, AUTOCLAVABLE
• Common Device Name: HD AUTOCLAVABLE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, ds 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: 16053115
• Report Number: 9610773-2022-00744
• Device Sequence Number: 6220070
• Product Code: FGC
• UDI-Device Identifier: 04042761077491
• UDI-Public: 04042761077491
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: WA2T400A
• Device Catalogue Number: WA2T400A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2016
• 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