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

Model Number	8403XSI
Medical Device Problem Codes	Device Reprocessing Problem (1091); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
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.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 "the wire is depressed.There is no image." no negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information refelected in section b5 correction in h6 health impact effect code the event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information: before the surgery, the user checked the unit and found that there was no image output.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluation: the technical examination of the returned product confirmed the fault described by the customer.Following defects were found: ---led flashes.---no image.---camera insert damaged.---circuit board defective.---button damaged/defective.The damage identified by the manufacturer is attributable to improper use.The damaged camera insert and a defective circuit board, which is attributable to excessive force, are the cause of the fault described by the customer.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
• MDR Report Key: 22082433
• Report Number: 9610617-2025-00902
• Device Sequence Number: 20838802
• Product Code: CCW
• UDI-Device Identifier: 04048551408315
• UDI-Public: 04048551408315
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 12/11/2025

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: 8403XSI
• Device Catalogue Number: 8403XSI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 12/08/2025
• Initial Report FDA Received Date: 05/24/2025
• Supplement Report FDA Received Date: 05/30/2025; 12/11/2025
• 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