MAUDE Adverse Event Report: KARL STORZ SE & Co. KG HOPKINS Telescope 30°, 10 mm, 31 cm

Model Number	26003BA
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to manufacturer for evaluation as reflected in section d9.The investigation is not yet complete, investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: foggy.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 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 ; +1(424)218-8247
• MDR Report Key: 50199912
• Report Number: 9610617-2026-01905
• Device Sequence Number: 10337401
• 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
• 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): 08/10/2026

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: 26003BA
• Device Catalogue Number: 26003BA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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