MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 45°, 460 MM, QUICK LOCK, AUTOCLAVABLE; AUTOCLAVABLE TELESCOPE

Model Number	WA52006A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection confirmed the customer reported defect, the optical system is loose/sunken, and the image has a shadow/halo.No moisture was observed in the optical system.The inspection also noted a minor dent on the rigid outer tube shaft and corrosion around the distal objective window frame.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.
Event or Problem Description
Olympus was informed by sterile processing manager at the user facility that the customer quick lock autoclavable telescope has a broken or loose lens defect, ¿lens misaligned¿.The reported defect was found at reprocessing.No death injury or infection and no person or other was affected has been reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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, it is likely that the event occurred due to user error, improper handling, as well as application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 45°, 460 MM, QUICK LOCK, AUTOCLAVABLE
• Common Device Name: AUTOCLAVABLE 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: 16069149
• Report Number: 9610773-2022-00789
• Device Sequence Number: 6160231
• Product Code: GCJ
• UDI-Device Identifier: 04042761052726
• UDI-Public: 04042761052726
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: WA52006A
• Device Catalogue Number: WA52006A
• Device Lot Number: 652757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2013
• 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