MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #0

Model Number	8404EXC
Medical Device Problem Codes	Device Reprocessing Problem (1091); Electrical /Electronic Property Problem (1198); Optical Problem (3001)
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 manufacturer on april 24,2025.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).
Event or Problem Description
It was reported that the product failed.Insufficient light.No harm to patient, user or third and no patient involvement reported.
Additional Manufacturer Narrative
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer insufficient light for performing laryngoscopy" was confirmed, and further defects were detected.In total the following defects were detected: -led does not light up -adhesive points on camera head worn -leak on camera head -cover worn -cover discolored.As stated, the device passed the quality check at the time of delivery.Based on the defects found during the technical inspection it is concluded that the most likely cause for the described error is the wear of the adhesive at the tip of the c-mac blade, coming from wear and tear during use and the reprocessing process.The wear of the adhesive causes liquid to penetrate the blade, which affects the electronics and causes the light is weak.If new or additional relevant information or the product will be received, we will reopen the investigation accordingly.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #0
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #0
• 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: 21955683
• Report Number: 9610617-2025-00781
• Device Sequence Number: 7272916
• Product Code: CCW
• UDI-Device Identifier: 04048551441992
• UDI-Public: 04048551441992
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/26/2025

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: 8404EXC
• Device Catalogue Number: 8404EXC
• Device Lot Number: SL3136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/26/2025
• 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