MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 5 MM, 29 CM

Model Number	R26046AA
Medical Device Problem Codes	Particulates (1451); Dent in Material (2526); Material Deformation (2976); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported the scope had cloudy and cracked lens.No harm to patient, user or third reported.Cross reference mdr: 9610617-2025-00384, 9610617-2025-00385, 9610617-2025-00387, 9610617-2025-00388, 9610617-2025-00389.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).Cross reference: complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the customer's statement "the scope had cloudy and cracked lens" cannot be confirmed.The imaging is clear, sharp and distinct.During the examination, no damaged/broken rod lenses could be detected.The shaft is minimally bent, but this has no functional effect on the imaging.There are dirt particles on the eyepiece diaphragm, which may have been caused by the application and the bent shaft.At the distal end, there is a minimal impact mark that does not affect the tightness or imaging.The detected damage was not caused by a production error/manufacturing defect.The damage was most likely caused by clinical application/reprocessing.This event is filed under internal complaint id (b)(4).Cross reference: complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21540555
• Report Number: 9610617-2025-00386
• Device Sequence Number: 8050445
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 04048551092088
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: R26046AA
• Device Catalogue Number: R26046AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 01/08/2026
• 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