VALLEYLAB FORCE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-13 for VALLEYLAB FORCE * manufactured by Covidien.

Event Text Entries

[4675410] At end of surgery, circulator noticed a nearly dime sized red raw are above the midline of the cearean section incision. When surgeon asked what caused the injury he stated" that is was a burn from the malfunctioning bovie. " at the start of the procedure the bovie malfuctioned and went into an error mode. Bovie unplugged and restarted and it read error again. When surgeon tried to use it, once again it did the same malfunction. New bovie obtained for surgery and malfunctioning bovie removed from room by biomed. Device tested by biomed, no problems found, all required tests are within normal operating parameters, returned to service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3890035
• MDR Report Key: 3890035
• Date Received: 2013-12-13
• Date of Report: 2013-12-13
• Date of Event: 2013-08-19
• Report Date: 2013-12-13
• Date Reported to FDA: 2013-12-13
• Date Reported to Mfgr: 2014-06-24
• Date Added to Maude: 2014-06-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VALLEYLAB FORCE
• Generic Name: UNIT, ELECTROSURGICAL
• Product Code: FAR
• Date Received: 2013-12-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-12-13