MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Video telescope "ENDOEYE HD II", 5.4 mm, 30°, autoclavable; rigid video laparoscope

Model Number	WA50052A
Medical Device Problem Codes	Break (1069); Contamination (1120); Poor Quality Image (1408); Dent in Material (2526); Output Problem (3005); 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 the rigid video laparoscope had a green image during reprocessing.During the initial evaluation of the device, fiber breakage, minor scratches on the frame, dents and scratches on the outer tube, failed light transmission, and minor stains under the light guide cover glass were observed.No patient involvement 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 and identified during the inspection have been confirmed.A 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.Additionally, the most probable cause of the malfunctions, fiber breakage, minor scratches on the frame, dents and scratches on the outer tube, and failed light transmission, was traced to component failure, and the cause of the minor stains under the light guide cover glass could not be established.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, 30°, 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: 50868545
• Report Number: 9610773-2026-06309
• Device Sequence Number: 9425912
• Product Code: HET
• UDI-Device Identifier: 04042761075015
• UDI-Public: 04042761075015
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: WA50052A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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