MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video-Optik "ENDOEYE 3D", 30°; rigid video laparoscope

Model Number	WA50082A
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rigid video laparoscope had the image switches intermittently.During the initial evaluation of the device it was observed, image not displayed and broken charged coupled device (r unit) were observed.No patient harm was reported.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The final investigation has been completed.The failure reported by the customer was not confirmed and failure identified during the inspection have been confirmed.A definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the reported malfunction could not be determined.The cause of the no image was due to the video cable is broken.Additionally, the cause of the malfunction was traced to the component failure.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-Optik "ENDOEYE 3D", 30°
• Common Device Name: rigid video laparoscope
• 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: 50479166
• Report Number: 9610773-2026-05829
• Device Sequence Number: 15980792
• Product Code: GCM
• UDI-Device Identifier: 04042761083492
• UDI-Public: 04042761083492
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K193026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: WA50082A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown