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

Model Number	8403XSP
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Crushing Injury (1797)
Date of Event	07/15/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been returned as of yet; therefore, an evaluation has not been conducted.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610617-2022-00242
• Device Sequence Number: 20430614
• Product Code: CCW
• UDI-Device Identifier: 04048551164372
• UDI-Public: 04048551164372
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 8403XSP
• Device Catalogue Number: 8403XSP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 01/05/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/11/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 4 YR
• Patient Sex: Unknown