MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC CONNECTING CABLE

Model Number	8403X
Medical Device Problem Codes	Intermittent Continuity (1121); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet completed, investigation results are pending.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported there was an intermittent connection issue with the device.No patient or procedure involvement.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the fault description provided by the customer was confirmed.The device had passed quality control at the time of delivery.Based on the defects identified during the technical inspection, it is concluded that the cause of the described malfunction is mechanical damage caused by the user.The broken plug can lead to sporadic failure of the image and light transmission connection.The cause of the defect is therefore improper use of the product.The investigations conducted no causes related to the labeling, the device, or its history.All production-related quality tests were passed, and no deviations were found in the device's manufacturing documentation.The labeling contained appropriate instructions and warnings.No systematic defect was identified.Should new or additional relevant information become available, we will continue the investigation accordingly.This event is filed under internal complaint id (b)(4).

• Brand Name: C-MAC CONNECTING CABLE
• Common Device Name: C-MAC CONNECTING CABLE
• 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: 23096398
• Report Number: 9610617-2025-01650
• Device Sequence Number: 18471814
• Product Code: CCW
• UDI-Device Identifier: 04048551389225
• UDI-Public: 04048551389225
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/11/2026

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: 8403X
• Device Catalogue Number: 8403X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 05/11/2026
• 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