MAUDE Adverse Event Report: KARL STORZ SE & CO.KG HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM

Model Number	R26046BRA
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408); Dent in Material (2526); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Its been reported the scope had grainy there is no information that the event caused a harm or serious injury to patient, user or third.Since the risk analysis is based to patient, user or third party harms no risk-id is applicable to the reported event.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).

• Brand Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM
• Common Device Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM
• Manufacturer (Section D): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 23842591
• Report Number: 9610617-2025-02455
• Device Sequence Number: 15942183
• Product Code: OWN
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: R26046BRA
• Device Catalogue Number: R26046BRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 06/25/2026
• 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