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

Model Number	26606BCA
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Defective Component (2292); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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
The following was reported: "the patient was already on the operating table.During installation on the table prior to surgery, a prompt "incompatible camera" appeared, and there was no image on the screen.Normal function was restored after replacing the scope.No significant surgical delay was caused." no negative impact in state of health reported.
Additional Manufacturer Narrative
Investigation: the device in question (26606bca, tipcam1 rubina 30°, opal1 nir/icg, 4k 3d, serial number (b)(6) was received by the manufacturing site in germany on jan 28, 2026 for investigation.The device was sent to the karl storz assessment and repair department for inspection.During the technical inspection, the error description provided by the customer, "incompatible camera", could be confirmed.During the inspection of the optics, impact marks/deformations were found in the distal edge area.According to the electronic measurement, the connection cable is not functioning.The damage found is not attributable to a production/manufacturing defect.At the time of the inspection, the operating hours read out were 224 operating hours and 137 application hours.The damage is attributable to clinical use and wear and tear.The above investigations did not reveal a root cause related to the labelling, the device, or its history.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: 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: 24254743
• Report Number: 9610617-2026-00208
• Device Sequence Number: 8326863
• 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): 09/15/2026

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: 26606BCA
• Device Catalogue Number: 26606BCA
• Was Device Available for Evaluation?: No
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 05/05/2026; 09/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/13/2026; 09/15/2026
• 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