MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 5 MM, 29 CM

Model Number	26046BA
Medical Device Problem Codes	Poor Quality Image (1408); Scratched Material (3020)
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 "foggy".No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: 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, "foggy", could not be confirmed.During the technical inspection of the optical component, mechanical damage was identified at the distal end, consisting of impact marks around the edge and scratches on the surface.Furthermore, the distal solder joint has been chemically corroded but remains fully functional in terms of sealing.The fogging described by the customer could not be reproduced.The damage identified is not attributable to a production or manufacturing defect but is caused by clinical use and clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 5 MM, 29 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: 24867185
• Report Number: 9610617-2026-00814
• Device Sequence Number: 10517636
• Product Code: GCJ
• UDI-Device Identifier: 04048551092132
• UDI-Public: 04048551092132
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K221004
• 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): 05/27/2026

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: 26046BA
• Device Catalogue Number: 26046BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/27/2026
• 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