FDA Adverse Event Malfunction Summary report: N

GOLD PROBE?

MDR report key: 3142155 · Received June 3, 2013

Report

Report Number: 3005099803-2013-04176
Event Type: Malfunction
Date Received: June 3, 2013
Report Date: May 9, 2013
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Product Code: KNS
PMA / PMN Number: K970278
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) FOR THE REPORTED EVENT: PROBE FAILS TO DELIVER ENERGY. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WAS NOT GENERATING HEAT, AND WAS NOT BURNING AT ALL. THE DEVICE HAD BEEN CHECKED PRIOR TO USE, AND HAD NO VISIBLE DAMAGE; THERE WAS ALSO NO PACKAGING DAMAGE NOTED. THERE WAS NO PROBLEM CONNECTING THE GOLD PROBE TO THE GENERATOR. THE GENERATOR AND ADAPTOR CABLE WERE CHECKED, AND WAS WORKING PROPERLY. A RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
244238	GOLD PROBE?	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	BOSTON SCIENTIFIC - COSTA RICA (COYOL)	M00560100	0015881286

Patients

Seq	Age	Sex	Outcome	Treatment
1