FDA Adverse Event Malfunction Summary report: N

MICROFRANCE® INSTRUMENT

MDR report key: 4702629 · Received April 17, 2015

Report

Report Number: 9680837-2015-00034
Event Type: Malfunction
Date Received: April 17, 2015
Report Date: March 25, 2015
Manufacturer: XOMED MICROFRANCE MFG
Product Code: GEI
PMA / PMN Number: K993655
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: TUBE CEV649-5B DIA 5MM 310MM, LOT: 140105, 510K: K993655, PRODUCT CODE: GEI, MANUFACTURED DATE:(B)(6)2014. (B)(4). FOUR DEVICES WERE RETURNED FOR EVALUATION: PART # CEV649-5B, LOT 140201 (QUANTITY # 3) <(>&<)> PART # CEV649-5B, LOT 140105 (QUANTITY # 1). THE PRODUCT ANALYSIS SHOWED THE SAME RESULTS FOR BOTH LOT NUMBER 140201 (QTY 3) AND LOT NUMBER 140105 (QTY 1). THE TUBES FAILED THE ELECTRICAL TESTS. THEIR SHEATHS ARE DAMAGED, MOSTLY ON THE DISTAL PARTS. THE TUBES ARE BENT ON THEIR PROXIMAL PARTS. THE INSULATION INTEGRITY IS COMPROMISED AND THE TUBES SHOULD NOT BE USED IN THIS CONDITION WITH MONOPOLAR INSTRUMENTS BECAUSE OF THE RISK OF ELECTRICAL ARCS. THESE TUBES WERE PROBABLY DAMAGED DURING THEIR USES AND REPROCESSINGS. THE DAMAGES MAY COME FROM IMPACTS WITH OTHER INSTRUMENTS, DISASSEMBLY WITH PLIERS, FALLS, ETC.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE HOSPITAL ACQUIRED A DEVICE TO MEASURE THE ELECTRICAL CURRENT, AND IT DETECTED A LEAK ON THE DEVICES. THE DEVICES WERE THEN SENT IN FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
257177	MICROFRANCE® INSTRUMENT	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	XOMED MICROFRANCE MFG	CEV649-5B	140201

Patients

Seq	Age	Sex	Outcome	Treatment
1