MAUDE Adverse Event Report: APPLIED MEDICAL APPLIED; TROCAR

Model Number SK100 CTF03

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2016

Event Type  malfunction  

Event Description

A small piece of broken black valve in the port.

• Brand Name: APPLIED
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; rancho santa margarita CA
• MDR Report Key: 5836190
• MDR Text Key: 50959029
• Report Number: MW5063742
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SK100 CTF03
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR