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

Model Number	WA50082A
Medical Device Problem Codes	Break (1069); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the initial evaluation of the rigid video laparoscope, it was found that the cover glass of the insertion section contained residual liquid and was cracked.There was no patient involvement.
Additional Manufacturer Narrative
Based on the final investigation of the device cover glass of the insertion section contains residual liquid and cover glass of the insertion section is cracked.The initial evaluation finding was confirmed.A root cause for the reported malfunction cover glass of the insertion section contains residual liquid could not be established.However, the most likely cause of the issue cover glass of the insertion section is cracked was determined to be component failure.Olympus will continue to monitor the field performance of this device.Should any additional relevant information become available, a supplemental report will be submitted.

• 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: 50478436
• Report Number: 9610773-2026-05825
• Device Sequence Number: 16051285
• Product Code: GCM
• UDI-Device Identifier: 04042761083492
• UDI-Public: 04042761083492
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: Other
• Device Model Number: WA50082A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2018
• 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