MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #3

Model Number 8404AXC

Device Problems Improper Chemical Reaction (2952); Optical Problem (3001)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the cmac blade light was not sufficient during use when connected to cmac monitor which resulted in escalation of surgical airway.As a result, anesthetist resulted to performing a surgical airway.

Manufacturer Narrative

This report is to clarify that the product was returned on november 21, 2023 for evaluation.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Most probable root cause is the wear of adhesive on the tip of the c-mac blade caused by reprocessing.Consequently, liquid is entering the blade and affects the electronic and forces the led to fail/ light dimly.Further, the image sensor is influenced by the entered liquid and shows some stripes in the display.

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #3
• Type of Device: C-MAC VIDEO LARYNGOSCOPE
• 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: 18535927
• MDR Text Key: 333148717
• Report Number: 9610617-2024-00014
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551441909
• UDI-Public: 4048551441909
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8404AXC
• Device Catalogue Number: 8404AXC
• Device Lot Number: TN2162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/18/2024; 02/27/2024
• Supplement Dates FDA Received: 01/18/2024; 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention