MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "EndoEYE", 10 mm, 0°, NTSC, HD compatible, autoclavable; Laparoscopes, Video

Model Number	WA50011A
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408); Dent in Material (2526); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a black shadow in the upper right corner and side of the viewing area involving an olympus laparoscopes, video.Additionally, during the initial evaluation of the device, fiber breakage, dents, and scratches on the distal frame, and dents and scratches on the outer tube were observed.There was no patient injury reported.
Additional Manufacturer Narrative
The date of the event is unknown.Additional information will be provided once available.The final investigation has been completed.The failure reported by the customer, as well as the issues identified during inspection, were confirmed.Based on the results of the investigation a root cause could not be identified.Olympus will continue to monitor the field performance of this device and evaluate any additional information received through post-market surveillance activities.

• Brand Name: Video telescope "EndoEYE", 10 mm, 0°, NTSC, HD compatible, autoclavable
• Common Device Name: Laparoscopes, Video
• Manufacturer (Section D): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50857098
• Report Number: 9610773-2026-06288
• Device Sequence Number: 10053211
• Product Code: NWB
• UDI-Device Identifier: 04042761061728
• UDI-Public: 04042761061728
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2008
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown