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

Model Number 8401HX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 12/15/2020

Event Type  Death  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The 8401hx c-mac® video laryngoscope d-blade was sent to karl storz on 23rd december 2020 for investigation.Upon investigation it can be confirmed that the c mac blade was defective.The covering glass and the lens are missing.The bad image quality, as reported, during the procedure is most likely caused by a defective camera and/or residues present at the interfaces.As per confirmation by the hospital, the d-blade used was defective before the procedure, however the user/nurses did not remove the defective blade from the holder and also the user did not check the function of the device before use.As a consequence, the defective device was then used and caused a bad quality image during the procedure.The root cause is most likely due to user error to use the defective device and not check its function prior to its use.In the corresponding ifu 96076011en-us, v3.1 11/2019 below chapter 5.1 the user must to perform a visual and functional test before and after every use.Risk level and probability are still adequate.The event is filed under internal karl storz complaint id (200843848).

Event Description

It was reported that there was event with a c-mac videolaryngoscope d-blade.According to the information received, the patient had a difficult airway.After extubation it ended up in a situation where re-intubation was needed.It was tried to intubate with a d-blade and discovered that the picture on the monitor was blurry.The intubation did not succeed despite several attempts.Another cmac was fetched from the surgery department.At the same time an emergency tracheostomy was performed.The patient was revived for 30 minutes - the patient died.The bad visibility with the cmac caused extra confusion in an already challenging situation.Immediately afterwards the cmac situation was investigated.The monitor (hosp.Number (b)(6)) had been taken to the medical technology department the day before (b)(6) in order to be fixed due to bad picture quality.Earlier during the day of the event (before the emergency airway situation) the monitor had been returned to the nurse station´s desk without any written description of the repairs performed.The monitor was returned to its holder (it was assumed the monitor was fixed).After the situation and several phone calls it became clear that the medical technology department had found the monitor to be fully functional and that the problem is most obviously with the blade.

• Brand Name: C-MAC VIDEOLARYNG. D-BLADE
• Type of Device: C-MAC VIDEOLARYNG. 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: 16950085
• MDR Text Key: 315425746
• Report Number: 9610617-2023-00602
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

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: 8401HX
• Device Catalogue Number: 8401HX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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): Death