MAUDE Adverse Event Report: APPLIED MEDICAL FIRST ENTRY; TROCAR

Model Number CFF 73

Device Problem Inflation Problem (1310)

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

Event Date 09/05/2014

Event Type  malfunction  

Event Description

Trocar balloon did not inflate after insertion.The trocar was removed and another one placed.

• Brand Name: FIRST ENTRY
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho margarita CA 92688
• MDR Report Key: 4124713
• MDR Text Key: 4949666
• Report Number: 4124713
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/12/2014

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: Physician
• Device Model Number: CFF 73
• Device Catalogue Number: 12X100MM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2014
• Patient Sequence Number: 1