MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM

Model Number	11575A
Medical Device Problem Codes	Fracture (1260); Optical Problem (3001)
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 lens is foggy in the eye piece.There is no information that the event caused a harm or serious injury to patient, user or third.
Additional Manufacturer Narrative
Result of investigation: the customer's complaint can be confirmed.During investigation, a bent image conductor tube was discovered.The deformation of the image conductor tube had a negative impact on imaging, among other things.The deformation also caused most of the installed light guides to break, which further impeded clear imaging and had a negative impact.The damage found is not attributable to a manufacturing/production defect.Such damage can be caused by clinical use/clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM
• Common Device Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.3MM
• 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: 23089758
• Report Number: 9610617-2025-01645
• Device Sequence Number: 21458177
• Product Code: GCJ
• UDI-Device Identifier: 04048551006252
• UDI-Public: 04048551006252
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K012527
• 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): 10/29/2025

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: 11575A
• Device Catalogue Number: 11575A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/29/2025
• 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