MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 10 MM, 31 CM

Model Number	26003BA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Result of investigation: during the technical investigation of the returned product, the following was found: the customer's statement that the optical system is foggy/blurred can be confirmed.When imaging the optics, a clearly defined blurring can be seen in the lower left edge of the image.During the examination, a chip in a rod lens was detected, which has a negative effect on imaging and influences the image quality.Small impact marks and scratches can be seen in the distal area.Normal signs of wear can be seen on the surface of the optics.Improper handling during clinical use or during clinical reprocessing can cause damage to the rod lens system, which negatively affects imaging, as in this case.At the time of product testing / delivery no deviations were found.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The diagnosed issue is not caused by a production defect.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The hospital reported a blurred image / frequent fogging during procedure.No negative impact in state of health reported.

• Brand Name: HOPKINS TELESCOPE 30°, 10 MM, 31 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 10 MM, 31 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, ; GM
• 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: 23452098
• Report Number: 9610617-2025-01949
• Device Sequence Number: 18435350
• Product Code: GCJ
• UDI-Device Identifier: 04048551090473
• UDI-Public: 04048551090473
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223923
• 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
• Report Date (Section B): 11/03/2025

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: 26003BA
• Device Catalogue Number: 26003BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/03/2025
• 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