MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 12°, 4 MM, 30 CM

Model Number	26105FA
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the hysteroscopic resectoscope, the medical staff found blurry and abnormal images on the lens.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Accordingly, we would like to give a summary of our results regarding the reported issue.As the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The error description provided by the customer, "blurred image", could not be confirmed.A precise analysis of the cause cannot be carried out because the optic mentioned is not available for closer examination and also no serialnumber is available.One possible cause, based on the customer's description, could be mechanical or chemical damage to the imaging system.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 12°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 12°, 4 MM, 30 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: 24337828
• Report Number: 9610617-2026-00305
• Device Sequence Number: 9790644
• Product Code: HIH
• UDI-Device Identifier: 04048551093610
• UDI-Public: 04048551093610
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223885
• 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): 04/10/2026

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: 26105FA
• Device Catalogue Number: 26105FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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