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

Model Number	26092AMA
Medical Device Problem Codes	Chemical Problem (2893); Optical Obstruction (3002)
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
It was reported that the image is foggy.No patient involvement and no negative impact in state of health reported.
Additional Manufacturer Narrative
Investigation: examination of the present optics revealed a chemically attacked, leaking distal solder seam.In addition, there is an impact mark in the distal area.Due to the leaky distal solder seam, moisture was able to penetrate the rod lens system.Foreign particles are visible in the rod lens system which have no influence on the imaging in the focus area.The imaging of the optics is clear and sharp.Damage identified by the service evaluation: dist.Solder seam chem.Damaged/leaking.Moisture in the lens system.Distal end mechanically damaged.Conclusion: the information provided by the customer, "foggy", can be confirmed.When exposed to ice spray, condensation can be seen in the rod lens system.The condensation of the optics is due to the detected chemical damage of the distal soldered seam, which has a leak due to the chemical damage.Furthermore, foreign particles can be seen in the rod lens system, which may have been caused using the optics and by the existing mechanical damage.The foreign particles have no influence on the imaging in the focal area.The damage found is due to use, clinical processing and mechanical damage and was not caused by a production/manufacturing defect.The event is filed under internal karl storz complaint id: (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, 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: 21521113
• Report Number: 9610617-2025-00356
• Device Sequence Number: 20946137
• Product Code: FAJ
• UDI-Device Identifier: 04048551274941
• UDI-Public: 04048551274941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 26092AMA
• Device Catalogue Number: 26092AMA
• Device Lot Number: 4178495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/01/2025
• 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