MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC S IMAGER

Model Number 8403XSI

Device Problem Image Display Error/Artifact (1304)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The device was returned to manufacturer for investigation.After evaluation, the failure of the image turned off during use could not be confirmed.The device was fully functional.On the other hand, at the wire connection, there is a damage area potentially caused by frequent stretching and compression.This damaged connection might impact the image quality.If devices continue to be used further.No indication for a material or manufacturing related issue was found during the investigation.Since the failure could not be confirmed, the cause may be traced to user error such as operating the device with an low battery or failure to check the device before use.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

As reported: the or has placed the imager s in the single use spatula.Then the pocket monitor was put on and switched on.A picture was always visible, and the functional check was thus successfully completed.During intubation, the monitor simply turned off and was black.The battery was always charged and there was a spare battery on the trolley in the charging station.The incident involved a female patient on (b)(6) 2021.

• Brand Name: C-MAC S IMAGER
• Type of Device: C-MAC S IMAGER
• 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: 16950066
• MDR Text Key: 315462660
• Report Number: 9610617-2023-00606
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8403XSI
• Device Catalogue Number: 8403XSI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2018
• 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 Sex: Female