MAUDE Adverse Event Report: APPLIED MEDICAL KII FIOS FIRST ENTRY TROCAR; LAPAROSCOPIC TROCAR

Model Number CTF73

Device Problem Disconnection (1171)

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

Event Date 01/30/2017

Event Type  malfunction  

Event Description

Surgeon assistant noticed that applied medical kii fios first entry trocar "cap" was disconnecting from sleeve of trocar when an instrument was inserted through the trocar.Trocar was removed from field and replaced.Diagnosis or reason for use: laparoscopic robotic gastric bypass.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: no.

• Brand Name: KII FIOS FIRST ENTRY TROCAR
• Type of Device: LAPAROSCOPIC TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; rancho santa margarita CA 92688
• MDR Report Key: 6292974
• MDR Text Key: 66337657
• Report Number: MW5067573
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Model Number: CTF73
• Device Catalogue Number: CTF73
• Device Lot Number: 1274608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR