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

Model Number	8403X
Medical Device Problem Codes	Failure to Conduct (1114); Intermittent Continuity (1121); Device Handling Problem (3265)
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
Per manufacturer's investigation results: the technical inspection confirmed the fault description reported by the customer.The cause of the fault described by the customer and our technical investigation revealed that the cable had been bent too sharply due to improper use during the refurbishment process or application, causing damage and a loose connection.This incident could have been avoided if a functional test had been carried out in accordance with the instructions for use prior to the intervention.Should new or additional relevant information become available, we will resume the investigation accordingly.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.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: 23096392
• Report Number: 9610617-2025-01648
• Device Sequence Number: 9347298
• 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): 05/06/2026

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: 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: 04/28/2026
• Initial Report FDA Received Date: 09/19/2025
• 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