Device Problem
Device Contamination with Chemical or Other Material (2944)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date 05/11/2016
Event Type
malfunction
Manufacturer Narrative
The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was unable to be reviewed as no lot number was available.
Event Description
It was reported that during a procedure black debris was found in the trocar device when the scope was inserted into patient.No patient harm or consequences were reported.Additional information, including the device part number and patient updates were requested but it was reported that there was not any additional information available.