MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS RUBINA 30, NIR/ICG, 0 10 MM

Model Number	26003BRA
Medical Device Problem Codes	No Display/Image (1183); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
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
According to the information received from the first moment it has suffered fogging, but the situation got worse in surgery.During surgery they lost total vision.The surgery was scheduled for laparoscopy, but they were not able to see anything through optics, in the end they had to change the method of intervention to open surgery.
Additional Manufacturer Narrative
Additional information: as the customer did not return the device in question, it was not possible to perform a physical investigation of the product itself.However, the available information has been reviewed.The investigation was completed on july 30,2025.The device product history records (dhr) were not checked, as no lot code was provided.The reason for not returning the product was: 'they claim that the failure was due to the optical cap being misplaced.They tested it again and found that the light fits perfectly, with no external damage, and that the image and colour are both perfect.' according to the customer, the optics were checked by clinic staff, who concluded that the poor imaging was caused by an incorrectly positioned camera head.The customer claims that the optics work without any detectable defects.Therefore, user error is the conclusion.Based on the customer's information, the deviation in the imaging cannot be attributed to a manufacturing/production error.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS RUBINA 30, NIR/ICG, 0 10 MM
• Common Device Name: HOPKINS RUBINA 30, NIR/ICG, 0 10 MM
• 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: 22210989
• Report Number: 9610617-2025-01003
• Device Sequence Number: 8158696
• Product Code: OWN
• UDI-Device Identifier: 04048551436240
• UDI-Public: 04048551436240
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K201399
• 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): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26003BRA
• Device Catalogue Number: 26003BRA
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown