MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.

Model Number	27294AA
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that the rod lens came out during the surgery.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°, 18 FR.
• Common Device Name: HOPKINS TELESCOPE 6°, 18 FR.
• 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
• MDR Report Key: 23659217
• Report Number: 9610617-2025-02154
• Device Sequence Number: 10123633
• Product Code: FGA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232370
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 04/13/2026; 05/26/2026; 04/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 04/27/2026; 05/29/2026; 09/09/2026
• 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