FDA Adverse Event Malfunction Summary report: N

MICROVASIVE GOLD PROBE

MDR report key: 2260850 · Received September 22, 2011

Report

Report Number: 3005099803-2011-03284
Event Type: Malfunction
Date Received: September 22, 2011
Date of Event: August 30, 2011
Report Date: September 1, 2011
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: KNS
PMA / PMN Number: K885005
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT: SNARE FAILED TO CUT THROUGH TARGET POLYP. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION JUMBO OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE NURSE WAS ATTEMPTING TO REMOVE A POLYP WITHOUT CAUTERY AND THE SNARE WOULD NOT CUT THROUGH IT. THE NURSE REPORTED THAT THE SNARE FELT "BLUNT." THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION JUMBO OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MICROVASIVE GOLD PROBE	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	BOSTON SCIENTIFIC - COSTA RICA	M00562650	14239092

Patients

Seq	Age	Sex	Outcome	Treatment
1