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

Model Number	8403X
Medical Device Problem Codes	Optical Problem (3001); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, cmac failed mid intubation.Screen flicked and light went out on laryngoscope handle.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The affected device will not be returned for investigation to the manufacturer.Should additional information/investigation results become available, a supplemental report will be submitted.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 defect was identified: loose connection on the cable the customer reported malfunction and the findings from the technical investigation indicate that the cable had been bent excessively due to improper handling during reprocessing or use.This sharp bending caused damage and resulted in a loose connection.The event is filed under internal karl storz 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
• MDR Report Key: 22613030
• Report Number: 9610617-2025-01286
• Device Sequence Number: 20179574
• Product Code: CCW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/24/2026

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
• Device Lot Number: TP23811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/24/2026
• 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