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

Model Number	26046BRA
Medical Device Problem Codes	Fracture (1260); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the image was not clear.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: during the examination of the optics, no negative influence on imaging due to damage or possible manufacturing defects was found.During refocusing, a chip was found on a rod lens.There are foreign particles/splinters in the system.The customer's statement "image not clear" cannot be confirmed.During the examination of the optics, no negative influence on the imaging due to damage or a possible manufacturing defect was found.When focusing on the individual rod lens sections, a chip was found on one rod lens.Glass splinters can be seen in the rod lens system due to the chip.Further examination of the optics and the icg function also yielded no negative results.The imaging of the optics is clear and distinct in both white light mode and icg mode (blue, green).Normal signs of wear are visible on the optics.Regarding the rod lens chip, the damage could have been caused by clinical use/clinical reprocessing.No further measures will be taken.The above conducted 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 devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints, no trend was identified.The event is filed under internal karl storz 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, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22948597
• Report Number: 9610617-2025-01539
• Device Sequence Number: 9591405
• Product Code: OWN
• UDI-Device Identifier: 04048551436264
• UDI-Public: 04048551436264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 26046BRA
• Device Catalogue Number: 26046BRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/06/2025
• 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