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

Model Number	TL400
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was reported that, during a robotic laparoscopic sigmoidectomy procedure, prior to performing the anastomosis, no structures appeared fluorescent green after activation of the indocyanine green (icg) mode.After administering indocyanine green (icg) to the patient at the correct dilution and volume, the surgeon adjusted the settings to activate the fluorescence mode.The endoscope responded when this option was selected; however, no structures appeared fluorescent (green).An additional small dose of icg was administered, but visualization was still not achieved.The endoscope was then restarted, but this did not resolve the issue.The surgery was completed without the use of icg.There was no patient injury.No negative impact in state of health reported.Cross reference 9610617-2026-770.
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).

• 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: 24800999
• Report Number: 9610617-2026-00769
• Device Sequence Number: 21318294
• Product Code: FET
• UDI-Device Identifier: 04048551425695
• UDI-Public: 04048551425695
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: D415957
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• 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