FDA Adverse Event Malfunction Summary report: N

75MM SELECTABLE NEW TLC

MDR report key: 1880575 · Received October 22, 2010

Report

Report Number: 3005075853-2010-06021
Event Type: Malfunction
Date Received: October 22, 2010
Date of Event: September 30, 2010
Report Date: September 30, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K092577
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE; HOWEVER THERE WERE TWO FULLY FIRED CARTRIDGES PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. BATCH HISTORY REVIEW HAS BEEN COMPLETED WITH NO ANOMALIES REPORTED.

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SIGMOID RESECTION PROCEDURE, THE SURGEON WAS CONCERNED AS IT WAS NOTICED AFTER THE FIRING THAT THERE WERE LOOSE STAPLES AT THE END OF THE STAPLE LINE THAT WERE MALFORMED. THE DEVICE FIRED PROPERLY. THE STAPLES IN THE TISSUE WERE FORMED PROPERLY AND THERE WERE NO LEAKS AT THE STAPLE LINE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

Description of Event or Problem · 1

ASKU

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	75MM SELECTABLE NEW TLC	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.		G4TP9U

Patients

Seq	Age	Sex	Outcome	Treatment
1				CARTRIDGE