MAUDE Adverse Event Report: KARL STORZ SE & CO.KG HOPKINS TELESCOPE 0°, 5 MM, 29 CM

Model Number	R26046AA
Medical Device Problem Codes	Break (1069); Device Reprocessing Problem (1091); Image Display Error/Artifact (1304); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hazy image during procedure.The procedure was completed successfully with a less than 5 min delay.No negative impact 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 complaint id (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the technical inspection, the error description provided by the customer, " hazy image during procedure ", could be confirmed.The optics show a bent shaft, which caused one or more rod lenses to break.According to the customer, sudden blurring occurred during use, which was caused by overloading due to bending of the shaft and the subsequent breakage.An unknown residue can be seen behind the distal cover glass, which may indicate ultrasonic reprocessing.Glass splinters and foreign particles are visible in the rod lens system due to the breakage.The breakage and the resulting splinters have a negative impact on imaging.The defects/damage described are not attributable to a manufacturing/production error, but indicate damage caused by clinical use/clinical reprocessing.This event is filed under internal complaint id_(b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5 MM, 29 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: 23367462
• Report Number: 9610617-2025-01876
• Device Sequence Number: 18371653
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 04048551092088
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K935279
• 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: R26046AA
• Device Catalogue Number: R26046AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/23/2025
• 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