MAUDE Adverse Event Report: KARL STORZ SE & CO.KG HOPKINS TELESCOPE 0°, 1.9/2.1 MM

Model Number	27017AA
Medical Device Problem Codes	Poor Quality Image (1408); Dent in Material (2526); Chemical Problem (2893); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported there was black debris coming out of bottom of eye piece.Foggy.No patient involvement.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the technical inspection, the error description provided by the customer, "black debri coming out of bottom of eye piece.Foggy", could be confirmed.The optics show a slightly bent shaft.Foreign particles are visible in the edge area of the optical system's out-of-focus range, which negatively affect imaging.Furthermore, residues of unknown origin are visible on the distal cover glass.The distal solder seam is chemically and mechanically damaged.In addition to the above-mentioned defects, moisture ingress can be detected in the optical system.The defects mentioned cannot be attributed to a production/manufacturing error.The damage may have been caused by clinical use/clinical reprocessing.This event is filed under internal complaint id_(b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 1.9/2.1 MM
• Common Device Name: HOPKINS TELESCOPE 0°, 1.9/2.1 MM
• 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: 23418086
• Report Number: 9610617-2025-01942
• Device Sequence Number: 10300134
• Product Code: FAJ
• UDI-Device Identifier: 04048551073384
• UDI-Public: 04048551073384
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 27017AA
• Device Catalogue Number: 27017AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/29/2026
• 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