MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC® S PEDIATRIC IMAGER; ENDOSCOPIC VIDEO IMAGING SYSTEM

Model Number 8403XSP

Device Problem Optical Problem (3001)

Patient Problems Cardiac Arrest (1762); Crushing Injury (1797)

Event Date 07/15/2022

Event Type  Death  

Manufacturer Narrative

The device has not been returned as of yet; therefore, an evaluation has not been conducted.

Event Description

Customer reported that during a pediatric arrest of a 4-year-old, the camera worked, but there was no light.They were able to secure the airway with an igel, but sadly, the child did not make it for reasons that were beyond the airway.The customer indicated that the failure of the c-mac s pediatric imager had no bearing on the patient outcome, as the patient had sustained crush injuries and would not have survived.

Manufacturer Narrative

Per our prelimary evaluation in the u.S., it was confirmed that the unit has an image, but no light output.The unit is being sent to the factory in germany for further evaluation.

Manufacturer Narrative

Per the manufacturer's investigation report: the device was returned to karl storz for investigation and forwarded to the supplier viendis.The malfunction (missing functionality of the light source) can be confirmed.The supplier indicated that there is a cable break in the camera shaft and the camera shaft itself is worn.Further, the optical condition of the housing parts is bad (worn).The supplier indicated a user related error to be the root cause for the malfunction of this device.The other issues are rooted in wearing.

• Brand Name: C-MAC® S PEDIATRIC IMAGER
• Type of Device: ENDOSCOPIC VIDEO IMAGING SYSTEM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15182761
• MDR Text Key: 297423284
• Report Number: 9610617-2022-00242
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551164372
• UDI-Public: 04048551164372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 8403XSP
• Device Catalogue Number: 8403XSP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/22/2022; 01/05/2023
• Supplement Dates FDA Received: 10/11/2022; 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 4 YR