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

Model Number	26616BCA
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	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic laparoscopic prostatectomy, after about 3 hours of procedure time, the visualization of the patient cavity took on a green/yellow hue.The camera was cleaned and the white rebalanced.The issue returned after about 10 minutes and the camera returned to the dark, green/yellow state.The cleaning process was repeated intermittently.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: the investigation was conducted solely based on the customer's description, as the device (26616bca; tipcam1 rubina 30°, opal1 nir/icg, 4k 3d; sn/lot (b)(6); manufactured january 15, 2025) was not returned for physical inspection.The error description provided by the customer, " green/yellow image ", could not be confirmed.A precise analysis of the cause cannot be carried out because the tipcams mentioned are not available to us for closer examination.The device failure may be due to several causes (electrical, mechanical, connection faults, damaged product) which cannot be identified at this stage.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.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: 24670876
• Report Number: 9610617-2026-00635
• Device Sequence Number: 20103694
• Product Code: OWN
• UDI-Device Identifier: 04048551426166
• UDI-Public: 04048551426166
• Combination Product (Y/N): N
• 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): 04/14/2026

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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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