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

Model Number	8403X
Medical Device Problem Codes	Output Problem (3005); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with the connection between camera and screen.It freezes and then blacks out.It happened mid intubation.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the 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).
Additional Manufacturer Narrative
Device evaluation: the technical inspection confirmed the fault description reported by the customer.The following faults were identified: loose connection on the cable.The cause of the fault described by the customer and our technical investigation revealed that the cable was bent too sharply due to improper use during preparation or application, or possibly a device tower was driven over the cable, damaging the cable and causing a loose connection.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
• 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: 22099031
• Report Number: 9610617-2025-00931
• Device Sequence Number: 7390176
• Product Code: CCW
• UDI-Device Identifier: 04048551389225
• UDI-Public: 04048551389225
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/03/2025

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: 8403X
• Device Catalogue Number: 8403X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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