MAUDE Adverse Event Report: KARL STORZ SE & Co. KG C-MAC Video Laryngoscope MAC #4

Model Number	8404BX
Medical Device Problem Codes	Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was sent for inspection.During the technical inspection, the error description provided by the customer "loose connection when plugging it in" was not confirmed.No fault detected on the device.As stated, the device passed the quality check at the time of delivery.The event is filed under internal karl storz complaint id: (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: 50150329
• Report Number: 9610617-2026-01869
• Device Sequence Number: 18793484
• Product Code: CCW
• UDI-Device Identifier: 04048551441930
• UDI-Public: 04048551441930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/25/2026

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: 8404BX
• Device Catalogue Number: 8404BX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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