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

Model Number	26046BRA
Medical Device Problem Codes	Optical Problem (3001); Misassembly During Maintenance/Repair (4054)
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 manufacturer.This information is reflected in section d9.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 from the telescope was blurred.No negative impact in state of health reported.
Additional Manufacturer Narrative
During the technical inspection, the error description provided by the customer, " image blurred ", could be confirmed.Within the inspection of the optical system, significant residue was found behind the distal cover glass, suggesting that the optical system was opened improperly.This suspicion was confirmed by the presence of an adhesive seam at the joint, which deviates from karl storz specifications.Furthermore, dirt particles were found on the end faces of individual rod lenses, which is a further indication of improper third-party repair.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 fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24477388
• Report Number: 9610617-2026-00397
• Device Sequence Number: 9360766
• Product Code: OWN
• UDI-Device Identifier: 04048551436264
• UDI-Public: 04048551436264
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 04/14/2026

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: 26046BRA
• Device Catalogue Number: 26046BRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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