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

Model Number	8403XSI
Medical Device Problem Codes	No Display/Image (1183); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device doesn't turn on and consequently no image is shown during installation.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device is pending receipt by manufacturer.The investigation is not yet completed; investigation results are pending.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Device received by manufacturer as noted in section d9.The investigation is not yet completed, investigation results are pending.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per manufacturer's investigation results: the product was sent to karl storz for examination.The fault description provided by the customer could not be confirmed.The technical examination did not reveal any malfunction of the product.The instructions for use (ifu) provide detailed guidance on the proper operation of the product and its functions.This event is filed under internal complaint id (b)(4).

• Brand Name: C-MAC S IMAGER
• Common Device Name: C-MAC S 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 ; 4242188247
• MDR Report Key: 22904355
• Report Number: 9610617-2025-01481
• Device Sequence Number: 9089167
• Product Code: CCW
• UDI-Device Identifier: 04048551408315
• UDI-Public: 04048551408315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 8403XSI
• Device Catalogue Number: 8403XSI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 02/19/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 08/28/2025; 03/09/2026
• 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