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	Overheating of Device (1437); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the unit gets hotter than the 35 c indicated on the ifu".No negative impact in state of health reported.It was initially reported that "the unit gets hotter than the 35 c indicated on the ifu".No negative impact in state of health reported.According to further information the customer claims that the equipment is getting warmer and warmer.This causes him discomfort to work.It was indicated that the unit reached a temperature of 38°c.
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).
Additional Manufacturer Narrative
Results of investigation: during the technical inspection, the reported error ("unit gets hotter than the 35°c") could not be confirmed.During the investigation, no increased heat development could be detected or reproduced on the tipcam.A possible cause for excessive heating may be an incorrectly selected light cable or contamination on the connection surfaces of the light guide or the device-side light connection.The tipcam shows no negative characteristics in terms of function, imaging, and heat generation.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: 22212199
• Report Number: 9610617-2025-00982
• Device Sequence Number: 20872632
• 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): 09/28/2026

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
• Date Returned to Manufacturer: 05/16/2025
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 02/09/2026; 09/04/2026
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 02/25/2026; 09/28/2026
• 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