MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 12°, 4 MM, 30 CM

Model Number	26105FA
Medical Device Problem Codes	Poor Quality Image (1408); Chemical Problem (2893); Failure to Clean Adequately (4048)
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 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 "optical system: blurred image".No negative impact in state of health reported.
Additional Manufacturer Narrative
Accordingly, we would like to give a summary of our results regarding the reported issue.The evaluation results: the device was sent to the karl storz assessment and repair department for inspection.During the technical inspection, the error description provided by the customer, " blurred image ", could be confirmed.During the examination, an unknown residue was found on the distal cover glass, which is adversely affecting the imaging.Furthermore, the distal solder seam has been chemically corroded.Abrasion and foreign particles are visible in the rod lens system, which may have been dislodged during use.The deviations/damage identified are not attributable to a production/manufacturing defect but were caused during clinical use or by incorrect reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 12°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 12°, 4 MM, 30 CM
• 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: 24510352
• Report Number: 9610617-2026-00415
• Device Sequence Number: 21436461
• Product Code: HIH
• UDI-Device Identifier: 04048551093610
• UDI-Public: 04048551093610
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223885
• 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): 04/14/2026

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: 26105FA
• Device Catalogue Number: 26105FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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