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

Model Number	26606ACA
Medical Device Problem Codes	Defective Component (2292); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "it has stopped working after a short time of use and doubts the quality".No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the customer's statement "suddenly did not work" can be confirmed.To analyze the cause, the specified optics were connected to the imaging unit, but the start screen did not appear and there was no imaging function.Further investigation revealed a defect/damage to the connection cable, which caused the optics to fail.The damage to the connection cable is not due to manufacturing / production defect but was most likely caused during clinical use / reprocessing.The corresponding reprocessing instruction ri ticam1 rubina 0° opal1 nir/icg 4k 3d 26606aca_en_v46.2_02-2023_ri_ce states in chapter 9 visual inspection the following: "1.Remove the protection cap from the connector.- check products for the following points: - visible soiling, - damage and corrosion, - completeness, - dryness.Subject any products displaying visible soiling to another complete cleaning and disinfectionprocess.Discard damaged and corroded medical devices.Discard incomplete medical devices or replace missing parts.Dry the product by hand if necessary." furthermore, in chapter 10.1 functional check: "if the device does not fulfill one of the points listed below or if damage can be identified, see chapter 'maintenance, repair, servicing and disposal' in the instructions for use.The following tests must be carried out to detect functional limitations: check the surface of the product for mechanical integrity and changes.Check the labeling for legibility.Check the product for mechanical integrity.Check the correct positioning of the assembled components and, if necessary, also check the cleaning connector.Check the mobility of all mobile components, if necessary, once the components have been assembled in the case of products that can be dismantled.Check whether the end positions of the application part are reached.Check if the image is transmitted.Check whether light is transmitted and whether the surface of the light input and light output is dirty or damaged.Check and inspect the product annually." 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: Confocal Optical Imaging
• 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: 22082516
• Report Number: 9610617-2025-00843
• Device Sequence Number: 17869196
• Product Code: OWN
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/30/2026

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: 26606ACA
• Device Catalogue Number: 26606ACA
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 09/04/2026
• Initial Report FDA Received Date: 05/25/2025
• Supplement Report FDA Received Date: 01/13/2026; 09/30/2026
• 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
• Patient Sex: Unknown