MAUDE Adverse Event Report: COVIDIEN FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/08/2019

Event Type  malfunction  

Event Description

Last person to use the bovie did not replace it in protective holster.The bovie was accidentally deployed when someone leaned on it causing a 2cm burn on patient's left lower quadrant.It was immediately recognized by the sound of the equipment.The surgeon elected to cut the burn out and sutured.Dr aware and will speak to family regarding incident.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 8640103
• MDR Text Key: 146067768
• Report Number: 8640103
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA