MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 10 MM, 31 CM

Model Number	26003BA
Medical Device Problem Codes	Optical Problem (3001); No Apparent Adverse Event (3189)
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.This information is reflected in section d9.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
It was reported that fogging during use.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the customer's statement "fogging during use" cannot be confirmed.In relation to the customer's fault report, the optics were subjected to a vacuum test and compressed air was applied to the distal and proximal areas, which did not cause any fogging of the cover glasses.Furthermore, the distal and proximal ends were cooled down with ice spray to cause fogging.However, no fogging could be caused or reproduced.Further examination of the optics revealed minimal surface scratches at the distal end.The distal cover glass shows slight deposits that could be removed by manually wiping with alcohol.There are minimal residues in the rod lens system, but these have no negative impact on the image display.No further damage that could negatively affect the image display could be found on the optics available to us.A possible cause may have been a temperature difference between the optics and the patient's body temperature, which can lead to fogging.Another possible cause may be fogging or contamination of the camera head used, which led to image impairment.The examined optics comply with the currently valid specifications.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 10 MM, 31 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 10 MM, 31 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 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: 22115435
• Report Number: 9610617-2025-00871
• Device Sequence Number: 4122838
• Product Code: GCJ
• UDI-Device Identifier: 04048551090473
• UDI-Public: 04048551090473
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K223923
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 26003BA
• Device Catalogue Number: 26003BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• 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: 02/02/2026
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 02/10/2026
• 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