MAUDE Adverse Event Report: COVIDIEN FORCE TRIAD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 07/08/2015

Event Type  Injury  

Event Description

Pt in for robotics surgery.During case surgeon had complaints about monopolar not working properly.Connections were checked and bovie pad was resecured after finding that the connection point at the cord was lifted.No alarms on the machine had gone off.Monopolar cord was also replaced.After checking connections, cautery seem to work fine per surgeon.At the end of the case, the grounding pad was removed and an approximately one inch abrasion/burn was noted at the bovie pad edge opposite the connection point.Surgeon assessed site and applied silvadene cream to the site.Bovie and all pads, cords removed from service.Risk management contacted.

• Brand Name: FORCE TRIAD
• Type of Device: FORCE TRIAD
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 4921968
• MDR Text Key: 6429942
• Report Number: MW5044258
• Device Sequence Number: 1
• Product Code: ODA
• 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: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR