FDA Adverse Event Malfunction Summary report: N

HANDLE CEV669B DIA 5MM ANG BIPOLAR

MDR report key: 3836162 · Received May 28, 2014

Report

Report Number: 9680837-2014-00043
Event Type: Malfunction
Date Received: May 28, 2014
Date of Event: May 14, 2014
Report Date: May 20, 2014
Manufacturer: XOMED MICROFRANCE MFG
Product Code: GEI
PMA / PMN Number: K993655
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: TUBE CEV6795B DIA 5MM 310MM, 510K: K993655, LOT# 131203 MANUFACTURE DATE: DECEMBER 2013 BIPOLAR INSERT CEV634-1A MOUIEL, 510K: K993655, LOT# 140104, MANUFACTURE DATE: JANUARY 2014. NO PATIENT INVOLVEMENT. BURN OF DEVICE OR DEVICE COMPONENT. THE PRODUCT ANALYSIS OF HANDLE CEV669B DIA 5MM ANG BIPOLAR FOUND THAT THE BLACK PLASTIC PART IS BURNT AT THE CONNECTION. THE BURN OF THE PLASTIC PART IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC, PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). ANALYSIS OF CONCOMITANT DEVICE TUBE CEV6795B DIA 5MM 310MM FOUND NO FAULT OR NON-CONFORMITY. ANALYSIS OF CONCOMITANT DEVICE BIPOLAR INSERT CEV634-1A MOUIEL FOUND THAT THE INSERT IS ON SHORT CIRCUIT. THE ELECTRICAL TESTS FAILED. AFTER DISASSEMBLY, IT APPEARS THAT THE ELECTRICAL LEAK COMES FROM A DEFECT OF COATING UNDER THE TUBE ON ONE OF THE WIRES. CONSIDERING THE LOCALIZATION OF THE DEFECT -UNDER THE TUBE- THE RISK FOR THE PATIENT OR THE USER IS VERY LOW.

Description of Event or Problem · 1

IT WAS REPORTED THERE WAS A ¿BURN SMELL AFTER THE PLUGGING TO THE GENERATOR OF THE OPERATING ROOM."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
312943	HANDLE CEV669B DIA 5MM ANG BIPOLAR	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	XOMED MICROFRANCE MFG	CEV669B	121004

Patients

Seq	Age	Sex	Outcome	Treatment
1