MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC POCKET MONITOR SET

Model Number 8403XDK

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2023

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

It was reported that during a reanimation the image of the video laryngoscope disturbed 2 times which caused a delay of 4mins and 2 interruptions of the intubation.The procedure was completed with a spare device.According to the information received, the patient passed.According to the new information, the malfunction of the device has not caused the death of the patient.Nevertheless, the product has not yet been investigated therefore, and due to the death of the patient, the case is still reportable.

Event Description

New information was received: according to the new information, the malfunction of the device has not caused the death of the patient.Nevertheless, the product has not yet been investigated therefore, and due to the death of the patient, the case is still reportable.

Manufacturer Narrative

The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Additional information is provided in section g3 to provide aware date which was accidently missed from the second supplemental report of this event.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Due to the fact, that both products showed no failure during inspection, whether in a single test nor a combination test, the most probable root cause is a regular behavior of the pocket monitor which leads them to shut down after 10 minutes.This shutdown is announced twice (2 and 1 minute) before shutdown of the display.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC POCKET MONITOR SET
• Type of Device: C-MAC POCKET MONITOR SET
• 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: 18384511
• MDR Text Key: 331233750
• Report Number: 9610617-2023-00403
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551396186
• UDI-Public: 4048551396186
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 03/22/2024

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: 8403XDK
• Device Catalogue Number: 8403XDK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/15/2024; 03/12/2024; 03/12/2024
• Supplement Dates FDA Received: 01/25/2024; 03/22/2024; 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 8404AXC: C-MAC VIDEO LARYNGOSCOPE.
• Patient Outcome(s): Death