MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D

Model Number	26616BCA
Medical Device Problem Codes	Circuit Failure (1089); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Event or Problem Description
According to the information received, surgical image was lost and a blue screen was shown.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Investigation: accordingly, we would like to give a summary of our results regarding the reported issue.The device was not returned to the manufacturer for inspection.Therefore, no technical inspection could be carried out and the error description provided by the customer, "blue screen and image loss", could not be confirmed.But based on the failure description the most probable root cause is a component failure on the circuit board.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D
• 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: 23615566
• Report Number: 9610617-2025-02140
• Device Sequence Number: 21074909
• Product Code: OWN
• UDI-Device Identifier: 04048551426166
• UDI-Public: 04048551426166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212695
• 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
• Report Date (Section B): 04/17/2026

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: 26616BCA
• Device Catalogue Number: 26616BCA
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 04/17/2026
• 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