ADULT REM POLYHESIVE II PATIENT RETURN ELECTRODE * E7507

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-27 for ADULT REM POLYHESIVE II PATIENT RETURN ELECTRODE * E7507 manufactured by Covidien, Formerly Valleylab, A Division Of Tyco Healthcare.

Event Text Entries

[20008026] During the surgical procedure, the bovie and pencil flamed at the tip. No injury was sustained by the patient. What was the original intended procedure? Total abdominal hysterectomy; right salpingo-oophorectomy; bilateral pelvic lymph node dissection; peritoneal washings. Device #1is this a laboratory device or laboratory test? No. Device #2is this a laboratory device or laboratory test? No. Device #3is this a laboratory device or laboratory test? No. Device #4is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3226137
• MDR Report Key: 3226137
• Date Received: 2013-06-27
• Date of Report: 2013-06-27
• Date of Event: 2012-10-25
• Report Date: 2013-06-27
• Date Reported to FDA: 2013-06-27
• Date Reported to Mfgr: 2013-07-15
• Date Added to Maude: 2013-07-15
• 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: ADULT REM POLYHESIVE II PATIENT RETURN ELECTRODE
• Generic Name: ELECTROSURGICAL PATIENT RETURN
• Product Code: ODR
• Date Received: 2013-06-27
• Model Number: *
• Catalog Number: E7507
• Lot Number: 236977X
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
• Manufacturer Address: 5920 LONGBOW DR BOULDER CO 80301 US 80301

Device Sequence Number: 2

• Brand Name: STERILE MAJOR PACK BOVIE PENCIL
• Generic Name: ELECTROSURGICAL, CUTTING, COAGULATION
• Product Code: GEI
• Date Received: 2013-06-27
• Model Number: *
• Catalog Number: *
• Lot Number: 893695
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN RD-MPKB-2B MCGAW PARK IL 60085 US 60085

Device Sequence Number: 3

• Brand Name: EXTENDED COATED BLADE
• Generic Name: ELECTROSURGICAL, CUTTING, COAGULATION
• Product Code: GEI
• Date Received: 2013-06-27
• Model Number: *
• Catalog Number: E1450-6
• Lot Number: 235777X
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COVIDIEN FORMERLY VALLEY, A DIVISION OF TYCO HEALTHCARE
• Manufacturer Address: 5920 LONGBOW DR BOULDER CO 80301 US 80301

Device Sequence Number: 4

• Brand Name: FORCE FX
• Generic Name: GENERATOR, ELECTROSURGICAL, CUTTING, COAGULATION
• Product Code: GEI
• Date Received: 2013-06-27
• Model Number: FX-C
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 6 YR
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
• Manufacturer Address: 5920 LONGBOW DR BOULDER CO 80301 US 80301

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-06-27