MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #4

Model Number	8404BX
Medical Device Problem Codes	Mechanical Problem (1384); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a loose contact.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on april 14,2025.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
Result of investigation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer " loose connection" was not confirmed, but further defects were detected.In total the following defects were detected: blade worn.The device passed the quality check at the time of delivery.Based on the technical inspection, no image failure can be detected or reproduced.The worn blade has no effect on the image.Internal karl storz reference number: (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #4
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #4
• 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: 21905786
• Report Number: 9610617-2025-00683
• Device Sequence Number: 4059659
• Product Code: CCW
• UDI-Device Identifier: 04048551441930
• UDI-Public: 04048551441930
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 8404BX
• Device Catalogue Number: 8404BX
• Device Lot Number: WM3513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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