MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1S 4U RUBINA, OPAL1 NIR/ICG

Model Number	TH121
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported a misty and blurred image on the camera stack screen.The scope had been changed but did not solve the problem.The camera head lens had been cleaned but this also did not resolve the issue.Then the camera head had been changed for another similar unit, this took a few minutes to achieve.This resolved the problem and the surgery was able to proceed after approximately a 10 minute delay.No negative impact in state of health reported.

• Brand Name: IMAGE1S 4U RUBINA, OPAL1 NIR/ICG
• Common Device Name: IMAGE1S 4U RUBINA, OPAL1 NIR/ICG
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo
• MDR Report Key: 23791641
• Report Number: 2027009-2025-02325
• Device Sequence Number: 14839524
• Product Code: OWN
• UDI-Device Identifier: 04048551430569
• UDI-Public: 04048551430569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: TH121
• Device Catalogue Number: TH121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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