FDA Adverse Event Injury Summary report: N

ENDOSTAT ELECTROSURGICAL UNIT

MDR report key: 1920283 · Received December 10, 2010

Report

Report Number: 3005099803-2010-05162
Event Type: Injury
Date Received: December 10, 2010
Date of Event: November 20, 2010
Report Date: November 22, 2010
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: KNS
PMA / PMN Number: K913881
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EXACT PATIENT WEIGHT IS UNKNOWN, BUT WAS ESTIMATED TO BE 160 LBS. (B)(4) - PATIENT COMPLICATION OF TWITCHING. (B)(4) - PATIENT TWITCHING DURING POWER DELIVERY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, WHILE THE PHYSICIAN WAS PERFORMING A SPHINCTEROTOMY WITH A NON-BSC SPHINCTEROTOME, THE PATIENT WOULD TWITCH DURING POWER DELIVERY. THE PHYSICIAN WAS UTILIZING THE UNIT'S "BLEND" MODE AT 60HZ. THE ACCOUNT INDICATED THAT THE GROUNDING PAD WAS INTACT AND THE PATIENT WAS NOT TOUCHING THE RAILS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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	M0054080R0

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Other