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

Model Number	8404BX
Medical Device Problem Codes	Device Reprocessing Problem (1091); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: loose contact video image.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the manufacturer's technical inspection of the returned device, the error description provided by the customer " loose contact video image." was not confirmed.In total the following defects were detected: ---blade worn.---housing worn.---cover worn.---plug worn.---led lights up dimly.The device passed the quality test at the time of delivery.The technical inspection did not reveal the fault described.However, several defects were found that could have led to image errors.The signs of wear on the blade, the housing on the cover and the plug may have caused a loose connection, which could have led to a brief loss of image.It was also found that the led no longer shows full light intensity.These faults indicate improper use of the product.This event is filed under internal 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: 22866627
• Report Number: 9610617-2025-01457
• Device Sequence Number: 20741125
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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