MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 8403ZXK; C-MAC MONITOR FOR CMOS ENDOSCOPES, KIT

Model Number 8403ZXK

Device Problem Failure to Charge (1085)

Patient Problem Airway Obstruction (1699)

Event Date 12/14/2019

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 power supply is damaged - the control led is not working when plugged in.The charging control on the monitor does indicate that the device is not charged.The plug is damaged to a degree, that the connection in the plug got interrupted.The led on the power supply indicated the malfunction by not "burning", the charge control on the monitor also indicates that there is no charging.At the time of the incident most likely the battery was empty.

Event Description

It was reported that there was event with a c-mac monitor for cmos endoscopes.According to the information received a patient was admitted after successful resuscitation on (b)(6)2019.The airway could not be secured prehospital with intubation because the tongue was swollen.Therefore, the emergency physician had only been able to insert a laryngeal tube (lts).During re-intubation in the shock room, the c-mac monitor for cmos endoscopes failed after 10 seconds.Attempts to connect to different wall sockets via cable were unsuccessful.Since the emergency physician credibly reported that conventional intubation was impossible, the lts was reintroduced.Ventilation was possible with it, but not optimal.The patient died a short time later in the intensive care unit.

• Brand Name: 8403ZXK
• Type of Device: C-MAC MONITOR FOR CMOS ENDOSCOPES, KIT
• 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: 16950073
• MDR Text Key: 315425601
• Report Number: 9610617-2023-00600
• Device Sequence Number: 1
• Product Code: CCW
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2023

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: 8403ZXK
• Device Catalogue Number: 8403ZXK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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