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

Model Number	27005BA
Medical Device Problem Codes	Fogging (1253); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
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
During the technical inspection, the error description provided by the customer, "foggy", could be confirmed.During the examination of the optics, an unknown residue was found on the distal cover glass, which impaired imaging.The coating can be removed mechanically, restoring clear and sharp imaging.Abrasion and residues are visible in the blurred area of the rod lens system, but do not have a negative impact on imaging.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 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: 24072793
• Report Number: 9610617-2026-00068
• Device Sequence Number: 10226808
• Product Code: FAJ
• UDI-Device Identifier: 04048551001066
• UDI-Public: 4048551001066
• 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): 03/18/2026

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: 27005BA
• Device Catalogue Number: 27005BA
• 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: 03/18/2026
• 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