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	No Display/Image (1183); Dent in Material (2526); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rigid video laparoscope image went out during an inspection for use.During the initial evaluation of the device, dents and scratches were observed on the distal end.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: dents and scratches on distal end.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: no image caused by defected outer tube.The most probable cause of dents and scratches on distal end is traced to 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, 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: 50914699
• Report Number: 9610773-2026-06398
• Device Sequence Number: 5394571
• Product Code: HET
• UDI-Device Identifier: 04042761075015
• UDI-Public: 04042761075015
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190744
• Number of Events Summarized: 1
• Summary Report (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): 09/28/2026

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: 09/11/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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