FDA Adverse Event Malfunction Summary report: N

RF3000 RADIOFREQUENCY GENERATOR

MDR report key: 3954980 · Received July 24, 2014

Report

Report Number: 2134265-2014-04750
Event Type: Malfunction
Date Received: July 24, 2014
Date of Event: June 26, 2014
Report Date: June 27, 2014
Manufacturer: BOSTON SCIENTIFIC - SAN JOSE
Product Code: GEI
PMA / PMN Number: K000241
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MFR #: 2134265-2014-04397. IT WAS REPORTED THAT ROLL-OFF TOOK LONGER THAN ANTICIPATED. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF THE LIVER UTILIZING A 2.0/17/15 LEVEEN SUPERSLIM ELECTRODE AND A RF3000 RADIOFREQUENCY GENERATOR. AFTER ABLATING THE LESION WITH THIS DEVICE FOR 5MIN 30SEC, THE IMPEDANCE SHOWED THE HIGH VALUE, BUT THE DEVICE FAILED TO ROLL OFF. AN ERROR CODE WAS DISPLAYED, BUT CANNOT BE RECALLED BY THE USER. IT WAS FURTHER NOTED THAT THE PHYSICIAN MOVED THE NEEDLE DURING USE RESULTING IN A RISE AND FALL OF THE IMPEDANCE VALUE AND A CHANGE IN THE OUTPUT. ROLL-OFF WAS EVENTUALLY ACHIEVED AND THE USER INDICATED THIS LIKELY OCCURRED DUE TO MOVING THE TIP OF THE NEEDLE WHILE ABLATING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
434362	RF3000 RADIOFREQUENCY GENERATOR	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	BOSTON SCIENTIFIC - SAN JOSE	UNK372

Patients

Seq	Age	Sex	Outcome	Treatment
1