MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "ENDOEYE HD II", 10 mm, 30°, autoclavable; Laparoscope, Gynecologic

Model Number	WA50042A
Medical Device Problem Codes	Fracture (1260); Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure with use of the gynecologic laparoscope, the viewable image developed a green tint/discoloration on the screen.The device was replaced with a back-up device and the procedure was completed.During the initial evaluation of the device, it was observed that the fibre bonding in the outer tube area (distal end) is damaged and the video cable is broken (which resulted in the green image.)no patient harm was reported.
Additional Manufacturer Narrative
The device was returned to olympus, and the final investigation has been completed.The failure reported by the customer and identified during the inspection have been confirmed.The following malfunctions were identified: -the video cable is broken and therefore the image is green -the fibre bonding in the outer tube area (distal end) is damaged a dhr/service history review was conducted.No issues were identified.A definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the reported malfunction, "video cable is broken" is caused linked to device but unable to trace more specifically, which indicates that the problems are traced to the device, but the investigation could not identify the actual root cause (e.G.Design, manufacturing, component).A definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the reported malfunction, "fibre bonding in the outer tube area (distal end) is damaged" is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: Video telescope "ENDOEYE HD II", 10 mm, 30°, autoclavable
• Common Device Name: Laparoscope, Gynecologic
• Manufacturer (Section D): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50950835
• Report Number: 9610773-2026-06453
• Device Sequence Number: 9534408
• Product Code: HET
• UDI-Device Identifier: 04042761074971
• UDI-Public: 04042761074971
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K111788, K19
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: WA50042A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011050570¿10/24/2023¿00
• Patient Sequence Number: 1
• Patient Sex: Unknown