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

Model Number 8403HX

Device Problem No Display/Image (1183)

Patient Problem Cardiac Arrest (1762)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the d-blade was used for emergency intubation on itu.Sudden blackout of monitor attributed to misconnection at cable connection to d-blade.On inspection female component of connection is corroded.Team reverted to normal mackintosh laryngoscope blade for intubation.Patient condition post-op: patient was critically unwell and had period of cardiac arrest after intubation requiring chest compressions.Causation by storz screen blackout is not likely in this incident, stated in the "product complaint event details form".No death or (unanticipated) serious deterioration in state of health reported.According to the ifu, the devices must be checked before and after each use, e.G., for rust and corrosion.If anything is found, they should no longer be used.Although it was stated that "causation by storz screen blackout is not likely in this incident", because of the patient condition after intubation the case is deemed reportable.

• Brand Name: C-MAC VIDEO LARYNGOSCOPE D-BLADE
• Type of Device: D-BLADE
• 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: 18899077
• MDR Text Key: 337753250
• Report Number: 9610617-2024-00067
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8403HX
• Device Catalogue Number: 8403HX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2016
• 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