MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "ENDOEYE HD II", 5.4 mm, 0°, autoclavable; rigid video laparoscope

Model Number	WA50050A
Medical Device Problem Codes	Crack (1135); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported cracked lens during inspection for use, involving an olympus rigid video laparoscope.During the initial device evaluation, a cracked image was observed.There was no patient involvement.
Additional Manufacturer Narrative
E1- address - (b)(6).The final investigation has been completed.The failure reported by the customer and identified during the evaluation was confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the cracked objective lens was the cause of degraded/cracked image quality, and for the cracked objective lens, the most probable cause traced due to a component failure.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", 5.4 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: 50863155
• Report Number: 9610773-2026-06301
• Device Sequence Number: 13117953
• Product Code: HET
• UDI-Device Identifier: 04042761075008
• UDI-Public: 04042761075008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: WA50050A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• 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