MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "ENDOEYE HD II", 10 mm, 0°, autoclavable; rigid video laparoscope

Model Number	WA50040A
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the rigid video laparoscope displayed image noise during therapeutic laparoscopy procedure while the patient was under sedation.The intended procedure was completed using a backup device.During the initial evaluation of the device, the fiber bonding in the outer tube area at the distal end was damaged, and no image was displayed.No patient harm was reported.
Additional Manufacturer Narrative
The final investigation has been completed.The device was returned to olympus for inspection, and the reported failure and failure identified during the inspection have been confirmed.A root cause could not be identified.Based on the results of the investigation image is not displayed due to video cable is broken also for the other malfunction based on the results of the investigation, the most probable cause of the complaint was traced to 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 telescope "ENDOEYE HD II", 10 mm, 0°, autoclavable
• 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: 50846453
• Report Number: 9610773-2026-06266
• Device Sequence Number: 9923371
• Product Code: HET
• UDI-Device Identifier: 04042761074964
• UDI-Public: 04042761074964
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K190744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: WA50040A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2017
• 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