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

Model Number	TH121
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "image disappears during use." no negative impact in state of health reported.
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
There was no patient impact or adverse outcome associated with this event, as previously stated in the initial mdr.The reported issue has been confirmed to be a device malfunction.No further clinical consequences were identified the device in question was returned to manufacturer on february 13,2026.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• 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 carneros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24496871
• Report Number: 2027009-2026-00412
• Device Sequence Number: 10676467
• Product Code: OWN
• UDI-Device Identifier: 04048551430569
• UDI-Public: 04048551430569
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: TH121
• Device Catalogue Number: TH121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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