MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; VIDEO TELESCOPE ENDOEYE

Model Number	WA50011A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the autoclavable video telescope had a broken light.No patient was involved in this event and the planned procedure was therapeutic.
Additional Manufacturer Narrative
Fax numbers: (b)(4).The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation uncovered the following; a broken/detached light post.There were also dents/cracks/chipped throughout the device.The automatic control of light transmission was also defective.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.Olympus will continue to monitor the field performance of this device.
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 is attributable to improper handling by the user, more specifically subjecting the device to excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
• Common Device Name: VIDEO TELESCOPE ENDOEYE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16518749
• Report Number: 9610773-2023-00708
• Device Sequence Number: 19658648
• Product Code: NWB
• UDI-Device Identifier: 04042761061728
• UDI-Public: 04042761061728
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K090980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: WA50011A
• Device Catalogue Number: WA50011A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2009
• 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