MICROVASIVE GOLD PROBE

Report

Report Number: 3005099803-2010-04785
Event Type: Injury
Date Received: November 19, 2010
Date of Event: October 28, 2010
Report Date: October 28, 2010
Manufacturer: MEDICAL SCIENTIFIC
Product Code: KNS
PMA / PMN Number: K885005
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - THE REPORTED EVENT OF WIRE FAILED TO DELIVER CURRENT. THE COMPLAINANT INDICATED THAT THE DEVICE 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

NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT NUMBERS 3005099803-2010-04783, 3005099803-2010-04784, AND 3005099803-2010-04799 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, TWO POLYPS WERE REMOVED FROM THE PATIENT'S COLON WITH NO APPARENT COMPLICATIONS. HOWEVER, THE COMPLAINANT REPORTED THAT THERE WAS NO EVIDENCE OF BLANCHING WHEN CAUTERY WAS ACTIVATED. THE PHYSICIAN BELIEVED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE GENERATOR. SEVERAL HOURS LATER THE PATIENT WAS ADMITTED TO AN EMERGENCY ROOM DUE TO BLEEDING, AND A HEMOSTASIS PROBE AND SEPARATE GENERATOR WERE USED TO RESOLVE THE BLEED. IT WAS REPORTED THAT NEITHER A TRANSFUSION NOR HEMOSTASIS CLIPS WERE NEEDED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MICROVASIVE GOLD PROBE	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	MEDICAL SCIENTIFIC	M00562670

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention