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

Model Number	27005FA
Medical Device Problem Codes	Poor Quality Image (1408); Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, the scope is "foggy".No patient involvement reported.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Additional Manufacturer Narrative
Accordingly, we would like to give a summary of our results regarding the reported issue.The error description provided by the customer, "foggy", could be confirmed.During the examination of the optics, an unknown coating was found on the distal cover glass, which can be removed mechanically.The adhering residue has a negative effect on the image quality.Furthermore, minimal residues are visible in the negative area of the rod lens system, but these do not have a negative impact on the image quality.The distal solder seam is corroded.The residue on the distal cover glass can be removed mechanically.The damage/defects found are due to normal use/wear and tear or inadequate clinical reprocessing.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: 24072794
• Report Number: 9610617-2026-00066
• Device Sequence Number: 21388955
• Product Code: FAJ
• UDI-Device Identifier: 04048551073179
• UDI-Public: 04048551073179
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• PMA/510(K) Number: K243653
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 27005FA
• Device Catalogue Number: 27005FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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