MAUDE Adverse Event Report:; UNKNOWN TROCAR

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.

• Type of Device: UNKNOWN TROCAR
• Manufacturer Contact: jason anderson ; 5010 cheshire parway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5695638
• MDR Text Key: 47654627
• Report Number: 2134070-2016-00036
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/12/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1