MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

Model Number	R26120BA
Medical Device Problem Codes	Crack (1135); Decoupling (1145); Inadequate or Insufficient Training (1643); Dent in Material (2526); Improper Chemical Reaction (2952)
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 manufacturing site for 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 was reported the lens is cracked and the visibility has diminished during medical procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correction made in section d2b.The correct code is hih.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the optical inspection, a severely bent shaft was detected.There are residues in the rod system due to mechanical damage, the light connection socket is twisted, and the light-conducting fibers are exposed.The customer's statement that "the lens is cracked" cannot be confirmed.Examination of the optics revealed a severely bent shaft, which has led to significant impairment of imaging.Significant dirt particles are visible in the rod lens system, caused by excessive stress and existing mechanical damage.The light output of the optics is virtually non-existent.The cause of this is a mechanically twisted light connection socket.All light-conducting fibers were separated from the socket, meaning that adequate illumination of the surgical field is no longer possible.Furthermore, the optics show impact marks, scratches, and a chemically damaged distal solder seam in the distal area.The damage listed and identified during the examination was not caused by a manufacturing/production defect but was caused by clinical use/clinical reprocessing.No further measures will be taken.The complaint history did not reveal any pickup in similar complaints, no trend was identified.This event is filed under internal complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• 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: 22031469
• Report Number: 9610617-2025-00867
• Device Sequence Number: 18182821
• Product Code: HIH
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/10/2026

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: R26120BA
• Device Catalogue Number: R26120BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 03/23/2026
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 02/18/2026; 04/11/2026
• 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