FDA Adverse Event Malfunction Summary report: N

CONTOUR CUTTER STAPLER

MDR report key: 3870389 · Received June 12, 2014

Report

Report Number: 3005075853-2014-03949
Event Type: Malfunction
Date Received: June 12, 2014
Date of Event: April 17, 2014
Report Date: May 19, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K040038
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE FIRST FIRING WENT WITHOUT ISSUE. THE DEVICE WAS RELOADED FOR A SECOND TIME RELATED TO THE SURGEON COULD NOT GET DISTAL ENOUGH. THE DEVICE WAS FIRED AND WOULD NOT CUT. THE SURGEON HAD TO MANUALLY CUT WITH SCISSORS. THIS MADE A SMALL HOLE IN THE RECTUM BECAUSE IT WAS SO DISTAL AND PER THE SURGEON, ¿I COULD NOT SEE.¿ FINAL DONUT WAS NOT COMPLETE; I BELIEVE IT WAS ENCAPSULATED BECAUSE OF THE CUT BEING SO DISTAL. THERE WAS NO ISSUE WITH THE CIRCULAR. THERE WERE NO BUBBLES ON THE LEAK TEST AND THE PATIENT DID OKAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
348133	CONTOUR CUTTER STAPLER	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1