MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC® S PEDIATRIC IMAGER

Model Number	8403XSP
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "defect detected during functional check.No video transmission, no patient use.".No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Result of investigation: accordingly, we would like to give a summary of our results regarding the reported issue.The evaluation the error description provided was confirmed.The following defects were detected:- no image video imager defect.Based on the defects identified during the technical inspection, it is concluded that the described fault is due to video imager failure.The most probable cause is random component failure without any design or manufacturing issue.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC® S PEDIATRIC IMAGER
• Common Device Name: C-MAC® S PEDIATRIC IMAGER
• 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: 23968888
• Report Number: 9610617-2025-02409
• Device Sequence Number: 18111684
• Product Code: CCW
• UDI-Device Identifier: 04048551409558
• UDI-Public: 04048551409558
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 05/06/2026

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: 8403XSP
• Device Catalogue Number: 8403XSP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 05/06/2026
• 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