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

Model Number	TL400
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a robotic laparoscopic ventral hernia repair procedure, the resolution and color of the visualization was appearing red.The surgeon converted to laparoscopy because the image turned red when operating near the abdominal wall.According to the available information, the patient suffered a non-serious injury.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.Based on the available information, the experience of the investigator and similar complaints, the most probable root cause is the defect of the camera head cable shielding.This led consequently to disturbance of image during the use of high frequency units and fits to the failure description of customer "monitor intermittently goes blank".The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
This previously submitted supplemental (9610617-2026-00212) is being redacted.9610617-2026-00212 sup1 was filed inadvertently inadvertently.The additional information reported in 9610617-2026-00212 sup1 has been correctly reported in 9610617-2025-00212 sup 1.

• 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: 24302605
• Report Number: 9610617-2026-00212
• Device Sequence Number: 20119453
• Product Code: OWN
• UDI-Device Identifier: 04048551425695
• UDI-Public: 04048551425695
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 02/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/19/2026; 02/24/2026
• 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