MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 5.4 MM, 45°; TELESCOPE, RIGID

Model Number	WA4KL545
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus sales representative was informed that the customer ultra rigid telescope has a ¿bent shaft and damaged lens¿.The reported problem was found at reprocessing.No death, injury or harm was reported to olympus.
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection confirmed the reported issue, dents/corrosion on the outer tube and broken rod lens inside the optical system.The inspection also noted corrosion on the distal end window frame and the eyepiece window unit has dents.The cause of the reported issue cannot be determined at this time as 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.
Additional Manufacturer Narrative
This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.Although a definitive root cause of the defects could not be identified, it was determined that the broken lens, dented outer tube, and dented eyepiece funnel were likely caused by excessive force during use by the customer and the corrosion on the out tube was likely caused by incorrect reprocessing.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: TELESCOPE "ULTRA", 5.4 MM, 45°
• Common Device Name: TELESCOPE, RIGID
• 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: 15942377
• Report Number: 9610773-2022-00605
• Device Sequence Number: 12276848
• Product Code: GCJ
• UDI-Device Identifier: 04042761082891
• UDI-Public: 04042761082891
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150633
• 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): 04/21/2023

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: WA4KL545
• Device Catalogue Number: WA4KL545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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