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

Model Number	8403X
Medical Device Problem Codes	Optical Problem (3001); No Apparent Adverse Event (3189)
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 image gets dark when blade is contact with metal.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: during the manufacturer's technical inspection, the error description provided by the customer "image gets dark blade is in contact with metal" was not confirmed.The technical investigation was performed on all three devices and the customer complaint could not be confirmed.The monitor shows signs of wear, and the side video socket is damaged - this is where the cable connects to the blade, which is responsible for transmitting the image and all other signals to the monitor.If this is damaged, it can lead to a brief, sporadic failure.Although this was not identified during the inspection, it could still have been the cause of the image failure.Therefore, it was concluded that the cause of the described fault is mechanical damage to the side video socket, caused either by the user or during refurbishment.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 90245
• MDR Report Key: 23445483
• Report Number: 9610617-2025-01982
• Device Sequence Number: 20851578
• Product Code: IKD
• UDI-Device Identifier: 04048551389225
• UDI-Public: 04048551389225
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 04/28/2026

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: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 04/28/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8403X C-MAC CONNECTING CABLE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown