MAUDE Adverse Event Report: APPLIED MEDICAL CTF 73 TROCAR 12 MM TROCAR

Model Number CTF 73

Device Problem Break (1069)

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

Event Date 05/20/2016

Event Type  Other  

Event Description

Piece of 12 mm trocar broke off inside of pt.Piece was retrieved.No known effect to pt.

• Brand Name: CTF 73 TROCAR 12 MM TROCAR
• Type of Device: CTF 73 TROCAR 12 MM TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5710109
• MDR Text Key: 47142946
• Report Number: MW5062747
• 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: 06/07/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2019
• Device Model Number: CTF 73
• Device Lot Number: 1266846
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR