MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D

Model Number	26616ACA
Medical Device Problem Codes	Poor Quality Image (1408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 the endoscope image was blurry during procedure.It appeared as if the autofocus of the camera was not performing well.External monitors showed the same blur.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was not sent to the karl storz assessment and repair department for inspection.The error description provided by the customer, "blurred image", could not be confirmed.A precise analysis of the cause cannot be carried out, as the tipcam mentioned is not available to us for closer examination.Possible causes for the blurring at the edges described by the customer may be contamination or damage in the optical area.At this point in time, we are unable to determine the cause of image impairment.If the optics are made available to us for analysis, the report will be reopened, and an investigation will be carried out.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: TIPCAM1 RUBINA 0°, 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: 23884892
• Report Number: 9610617-2025-02428
• Device Sequence Number: 20026703
• Product Code: OWN
• UDI-Device Identifier: 04048551426180
• UDI-Public: 04048551426180
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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): 03/27/2026

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: 26616ACA
• Device Catalogue Number: 26616ACA
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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