MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 5 MM, 24 CM

Model Number	50251BA
Medical Device Problem Codes	Misfocusing (1401); Particulates (1451); Optical Problem (3001)
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 "foggy of image".No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the information provided by the customer "foggy of image" can be confirmed.The imaging is blurred and cloudy.When focusing through the optics, individual foreign particles can be detected in the rod lens system, which may have been introduced into the system during production.No exact cause of the clearly visible blurring could be diagnosed during further examination of the optics.One possible cause could be mechanical damage caused by an impact or shock that has shifted imaging components.It is also possible that parts of the imaging components have become detached / dislocated.This error is therefore classified as unassignable.No systematic cause of the fault can be identified.In the corresponding ifu 96216001d_v4.0_11-2017, page 9 the following is stated: "in order to test the image quality, slowly rotate the telescope while looking through it.If the image is completely or partially impaired, either the rod lens system in the sheath is broken or the lens in the eyepiece is defective.In such cases, the telescope must be replaced.A cloudy or speckled image can be caused by moisture or disinfectant residue on the optical end faces.Further on page 11: "place the telescopes down with care.Hard impacts, particularly to the distal end, can cause damage to or cracks in the luting and allow liquid, steam, etc.To penetrate.This results in cloudy and/or blurred image areas.Note: if damage is apparent, the telescope should no longer be used.Telescopes must be replaced if the image is cloudy or if no image or only parts thereof are visible." this event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 5 MM, 24 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 5 MM, 24 CM
• 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: 22051958
• Report Number: 9610617-2025-00886
• Device Sequence Number: 21057594
• Product Code: GCJ
• UDI-Device Identifier: 04048551171356
• UDI-Public: 04048551171356
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K935279
• 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): 11/25/2025

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: 50251BA
• Device Catalogue Number: 50251BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 11/25/2025
• 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