FORCE FX ELECTROSURGICAL GENERATOR E-8006 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-16 for FORCE FX ELECTROSURGICAL GENERATOR E-8006 * manufactured by Valleyab.

Event Text Entries

[313373] Prior to surgery, the patient was positioned and the boive pad was placed on the patient's left lateral thigh. The bovie pad was smooth against the site and had full contact with the patient's skin. The patient was not repositioned prior to the surgery beginning. During surgery, the bovie was not functioning properly. The cord and cutting loop were replaced and the bovie still was not functioning properly. It was observed that the boive pad was not in full contact with the patient's skin. The bovie pad was smoothed onto the patient's thigh for full skin contact. The bovie worked properly for the remainder of the surgery. When the bovie pad was removed, a burn was noticed on the patient where the pad was located.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 562253
• MDR Report Key: 562253
• Date Received: 2004-12-16
• Date of Report: 2004-11-23
• Date of Event: 2004-11-17
• Report Date: 2004-11-23
• Date Reported to FDA: 2004-12-16
• Date Added to Maude: 2005-01-03
• 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 Sequence Number: 1

• Brand Name: FORCE FX ELECTROSURGICAL GENERATOR
• Generic Name: ELECTROSURGICAL GENERATOR
• Product Code: GEI
• Date Received: 2004-12-16
• Model Number: E-8006
• Catalog Number: *
• Lot Number: 56346-3
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 551969
• Manufacturer: VALLEYAB
• Manufacturer Address: DIVISION OF TYCO HEALTHCARE GR 5920 LONGBOW DRIVE BOULDER CO 803013299 US

Device Sequence Number: 2

• Brand Name: POLYHESIVE RETURN ELECTRODE
• Generic Name: PATIENT RETURN ELECTRODE
• Product Code: JOS
• Date Received: 2004-12-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 551970
• Manufacturer: VALLEYLAB
• Manufacturer Address: DIVISION OF TYCO HEALTHCARE GR 5920 LONGBOW DRIVE BOULDER CO 803013299 US

Device Sequence Number: 3

• Brand Name: CUTTING LOOP
• Generic Name: CUTTING LOOP
• Product Code: JYQ
• Date Received: 2004-12-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 551971
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Manufacturer Address: ONE BOSTON SCIENTIFIC PLACE NATICK MA 017601537 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2004-12-16