MAUDE Adverse Event Report: APPLIED MEDICAL FIOS; TROCAR

Model Number CFB03

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Balloon on end of trocar would not deflate.

• Brand Name: FIOS
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; rancho santa margherita CA 92668
• MDR Report Key: 3840179
• MDR Text Key: 21529635
• Report Number: MW5036338
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2014

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: Health Professional
• Device Model Number: CFB03
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 164