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 10/27/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient was admitted to the emergency department with airway issues.The cmac blade used to perform initial investigation did not provide sufficient light during use when connected to cmac monitor which resulted in escalation to surgical airway procedure.

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.Internal karl storz reference number: (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #3
• Type of Device: VIDEO LARYNGOSCOP
• 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: 18120076
• MDR Text Key: 327933990
• Report Number: 9610617-2023-00374
• Device Sequence Number: 1
• Product Code: CCW
• 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
• Report Date: 03/07/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention