MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°

Model Number	26092AMA
Medical Device Problem Codes	Poor Quality Image (1408); Dent in Material (2526); Chemical Problem (2893); Material Deformation (2976); Scratched Material (3020)
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.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 "foggy".No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: accordingly, we would like to give a summary of our results regarding the reported issue.During the technical inspection of the returned device, the error description provided by the customer, "foggy" could be confirmed.During the examination of the optics, a chemically and mechanically damaged distal solder seam was detected.Furthermore, impact marks/deformations can be seen in the distal area and on the surface of the sheep.When viewing the imaging, negative focus areas of the optics are visible, which have a negative influence on the imaging and cause distortion/blurring in the imaging.Furthermore, material deformations can be detected around the distal light fibers.The defects/deviations found are not attributable to a manufacturing/production error.The mechanical damage and residues are attributable to clinical use or mechanical damage caused by clinical application/clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°
• Common Device Name: HOPKINS TELESCOPE 6°
• 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: 23852266
• Report Number: 9610617-2025-02350
• Device Sequence Number: 18541670
• Product Code: FAJ
• UDI-Device Identifier: 04048551274941
• UDI-Public: 04048551274941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K943176
• 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): 06/02/2026

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: 26092AMA
• Device Catalogue Number: 26092AMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 06/02/2026
• 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