MAUDE Adverse Event Report: KARL STORZ SE & CO. KG POWER LED RUBINA, OPAL1 NIR/ICG

Model Number	TL400
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that prior to pyeloplasty procedure, there was a frozen image error which was not dismissible.The surgical site was not visible when the image frozen occurred.The issue did not resolve even after turning off and on the tl400.The tc304 and tl400 was turned off and back on to resolve the issue.The patient was not present in the operating room when the event occurred.The patient was in the anaesthetic room.There was a 5 minute delay.No negative impact in state of health reported.Cross reference mdr: 9610617-2026-00435.

• Brand Name: POWER LED RUBINA, OPAL1 NIR/ICG
• Common Device Name: POWER LED RUBINA, OPAL1 NIR/ICG
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24552288
• Report Number: 9610617-2026-00436
• Device Sequence Number: 18512998
• Product Code: OWN
• UDI-Device Identifier: 04048551425695
• UDI-Public: 04048551425695
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 03/09/2026

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: TL400
• Device Catalogue Number: TL400
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• 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