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); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 complaint id: (b)(4).
Event or Problem Description
It has been reported there was black debri 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
Result of investigation: during the examination of the optics, poor imaging was detected, caused by a break in one or more rod lenses.The distal cover glass shows residues of unknown origin.The metal is pitted around the distal window.Thus, the inspection confirmed the error description provided by the customer: "black debri / foggy".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: 23418082
• Report Number: 9610617-2025-01941
• Device Sequence Number: 10300131
• 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): 12/11/2025

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: 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: 12/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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