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

Model Number	26092AMA
Medical Device Problem Codes	Decoupling (1145); Dent in Material (2526); Improper Chemical Reaction (2952); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the device shows problems with the optical system like foggy vision.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the examination revealed a chemically damaged distal solder joint.There are adhering residues/deposits on the distal cover glass that have not been cleaned off, leading to negative imaging.Impact marks are visible around the distal end.The light connection socket is mechanically loose.The customer's information (foggy/always) can be confirmed.Examination of the optics available to us revealed a chemically damaged distal solder joint.Furthermore, an unknown residue/deposit adhering to the distal cover glass can be seen, which was not cleaned off during clinical reprocessing.The coating/residue leads to negative imaging (foggy).Impact marks are visible around the distal end.The light connection socket is mechanically detached.The optical shaft itself is bent.The defects/damage found are not due to a production/manufacturing defect.Likely, the damage was caused by clinical use/clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°
• Common Device Name: HOPKINS TELESCOPE 6°
• 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
• MDR Report Key: 22717974
• Report Number: 9610617-2025-01365
• Device Sequence Number: 9583205
• Product Code: FAJ
• UDI-Device Identifier: 04048551274941
• UDI-Public: 04048551274941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K943176
• 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): 10/28/2025

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: 26092AMA
• Device Catalogue Number: 26092AMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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