MAUDE Adverse Event Report: FREEHOLD SURGICAL FREEHOLD TRIO FRE-T-5; RETRACTION DEVICE

Model Number FRE-T-5

Device Problems Device Slipped (1584); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 03/17/2015

Event Type  Injury  

Event Description

A (b)(6) male was undergoing a robotic-assisted gastric sleeve surgery.The freehold trio fre-t-5 wave was being used by the surgeon.As the surgeon was using the device to retract the liver for better visualization.One of the adjustable hooks of the device moved.The surgeon tried to retention the device, but the suture within the device appeared to be stuck.The surgeon removed the device and used an alternative retraction device.

• Brand Name: FREEHOLD TRIO FRE-T-5
• Type of Device: RETRACTION DEVICE
• Manufacturer (Section D): FREEHOLD SURGICAL; new hope PA 18938
• MDR Report Key: 4645312
• MDR Text Key: 21244851
• Report Number: MW5041718
• Device Sequence Number: 1
• Product Code: NAY
• 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: 03/25/2015

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 Expiration Date: 10/31/2016
• Device Model Number: FRE-T-5
• Device Lot Number: 75KD0306
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 152