FDA Adverse Event Malfunction Summary report: N

ENDOSTAT ELECTROSURGICAL UNIT

MDR report key: 2020004 · Received March 16, 2011

Report

Report Number: 3005099803-2011-00793
Event Type: Malfunction
Date Received: March 16, 2011
Date of Event: February 23, 2011
Report Date: February 23, 2011
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: KNS
PMA / PMN Number: K913881
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00795 AND 3005099803-2011-00797 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, AN ENDOSTAT FOOT SWITCH, AND A GOLD PROBE WERE USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WAS BEING USED TO RESOLVE A BLEED IN THE PATIENT'S STOMACH WHEN CAUTERY FAILED. AS A MALFUNCTION OF THE GENERATOR WAS SUSPECTED, EFFORTS TO CAUTERIZE WERE ABANDONED AND EPINEPHRINE WAS INJECTED (METHOD UNKNOWN) TO RESOLVE THE BLEED SUCCESSFULLY. 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 FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOSTAT ELECTROSURGICAL UNIT	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	BOSTON SCIENTIFIC - MARLBOROUGH	M00540800

Patients

Seq	Age	Sex	Outcome	Treatment
1