FDA Adverse Event Malfunction Summary report: N

TLS3 23C

MDR report key: 2222944 · Received August 10, 2011

Report

Report Number: 2954339-2011-00018
Event Type: Malfunction
Date Received: August 10, 2011
Date of Event: July 19, 2011
Report Date: August 9, 2011
Manufacturer: STARION INSTRUMENTS
Product Code: GEI
PMA / PMN Number: K062257
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ONE TLS3 23C WAS RETURNED, DECONTAMINATED AND INVESTIGATED. THE SERIAL NUMBER COULD NOT BE DETERMINED DUE TO THE CORD BEING CUT ON THE RETURNED TLS3 23C. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. THE RIGHT HAW BOOT WAS TORN ON THE OUTSIDE SURFACE, CONFIRMING THE COMPLAINT. THE TORN BOOT PIECE WAS NOT RETURNED. THERE ALSO WAS SUBSTANTIAL CHARRED TISSUE ATTACHED TO THE JAW BOOT. THE GAP BETWEEN THE HEAT SPREADER AND THE JAW WITH THE TORN BOOT WAS APPROPRIATE, NO DEFECTS WERE VISIBLE. THE BOOT TEAR IS CONSISTENT WITH JAWS THAT ARE NOT COMPLETELY CLOSED DURING INSERTION OR WITHDRAWAL OF THE DEVICE THROUGH A CANNULA. INCOMPLETE CLOSURE DURING CANNULA INSERTION AND/OR WITHDRAWAL CAN CAUSE THE JAWS TO BE SLIGHTLY APART FORCING THEM TO COME IN CONTACT WITH THE WALLS OF THE CANNULA AND THE BOOT AND OTHER COMPONENTS CAN GET DAMAGED. TEARS MAY ENLARGE WITH EXTENSIVE USE OR AGGRESSIVE CLEANING. NO ISSUES WERE FOUND WITH THE DEVICE HISTORY RECORD.

Description of Event or Problem · 1

DURING A RADICAL PROSTATECTOMY PROCEDURE, THE SCRUB TECH WIPED THE JAWS TO CLEAN THEM AND A SMALL PIECE OF THE VERY END OF THE SILICONE TIP CAME OFF. THIS DID NOT HAPPEN INSIDE THE PT, HOWEVER, IT WAS DURING THE SURGERY. NO OTHER PT INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TLS3 23C	LIGATING SHEAR 35 C	GEI	STARION INSTRUMENTS	132-135D	902003

Patients

Seq	Age	Sex	Outcome	Treatment
1