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

Model Number	R27092AMA
Medical Device Problem Codes	Optical Problem (3001); Insufficient Device Problem Information (3190)
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 (b)(4).
Event or Problem Description
It has been reported the scope had image issue during procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device will not 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).
Additional Manufacturer Narrative
Result of investigation: the device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection is not possible.The customer reported an "image issue.A precise analysis of the cause cannot be carried out because the product was scrapped and it is therefore no longer available.Based on the images provided to us by (b)(6), severe damage in the form of an impact mark/bruise in the distal area of the shaft is visible.Also clearly visible is the significant clouding of the distal cover glass, which could indicate a possible leak in this area.The detailed images show foreign particles in the rod lens system and almost complete shading of the optical system.Based on the damage visible in the images, we currently assume that the rod lens system has been mechanically damaged by external influences, which has had a significant negative impact on the imaging and made further use of the optics impossible.This event is filed under internal complaint (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, 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: 23920811
• Report Number: 9610617-2025-02464
• Device Sequence Number: 8763547
• Product Code: FAJ
• UDI-Device Identifier: 04048551233344
• UDI-Public: 04048551233344
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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: R27092AMA
• Device Catalogue Number: R27092AMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/10/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown