FDA Adverse Event Malfunction Summary report: N

POLYHESIVE RETURN ELECTRODE

MDR report key: 4132886 · Received October 1, 2014

Report

Report Number: 1717344-2014-00863
Event Type: Malfunction
Date Received: October 1, 2014
Date of Event: September 3, 2014
Report Date: September 17, 2014
Manufacturer: COVIDIEN LP
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE E7506 INSTRUCTIONS FOR USE WARNS THAT NON-TRADITIONAL PROCEDURES THAT UTILIZE HIGH CURRENT, LONG DUTY CYCLES, OR BOTH (FOR EXAMPLE: TISSUE LESIONING, TISSUE ABLATION, TISSUE VAPORIZATION, AND PROCEDURES IN WHICH CONDUCTIVE FLUIDS SUCH AS SALINE OR LACTATED RINGER'S SOLUTION ARE INTRODUCED INTO THE SURGICAL SITE FOR DISTENTION OR TO CONDUCT THE RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PATIENT. USE OF MORE THAN ONE RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A PATIENT HAD UNDERGONE A RENAL RFA PROCEDURE WITHOUT ANY COMPLICATIONS. THE PATIENT, UPON BEING DISCHARGED HOME, NOTICED SOME BLISTERS ON THE TOP OF HER THIGH. THE NURSING STAFF DID NOT NOTICE ANY BLISTERS ON HER THIGH UPON REMOVAL OF THE GROUNDING PAD IMMEDIATELY AFTER THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
612317	POLYHESIVE RETURN ELECTRODE	PATIENT RETURN ELECTRODE	GEI	COVIDIEN LP	E7506

Patients

Seq	Age	Sex	Outcome	Treatment
1