MAUDE Adverse Event Report: KARL STORZ SE & CO. KG IMAGE1S 4U RUBINA, OPAL1 NIR/ICG

Model Number	TH121
Medical Device Problem Codes	Poor Quality Image (1408); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that poor image quality is observed during surgery.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 indicating that both leading and concomitant products have been returned for evaluation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section h6 that was accidentally omitted in the last supplemental report.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "during surgery, poor image quality is observed", could not be confirmed.The cause can be attributed to a random software hang (tc304) or an incorrect connected cable (th121).The additional determined issues (software not current) are independent from the reported failure from customer.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.Furthermore, a spare device should be available in case the device fails during use.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 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: 23622516
• Report Number: 9610617-2025-02127
• Device Sequence Number: 15975140
• Product Code: OWN
• UDI-Device Identifier: 04048551430569
• UDI-Public: 04048551430569
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup
• Report Date (Section B): 04/20/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 04/02/2026; 02/04/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/12/2026; 04/13/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TC304 - SERIAL NUMBER (B)(6)
• Patient Sex: Unknown