FDA Adverse Event Malfunction Summary report: N

ETS LINEAR CUTTER

MDR report key: 4013063 · Received August 15, 2014

Report

Report Number: 3005075853-2014-05741
Event Type: Malfunction
Date Received: August 15, 2014
Date of Event: July 30, 2014
Report Date: July 30, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K020779
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: AT WHAT FIRING DID THE ISSUE OCCUR? STAPLES WENT EVERYWHERE AFTER BEING FIRED WHAT COLOR CARTRIDGE WAS BEING USED WHEN THE STAPLES WERE MALFORMED? BLUE WAS BUTTRESSING MATERIAL BEING USED? NO. DID THE PRIMARY SURGEON FIRE THE DEVICE? YES. WAS THERE ANY BLEEDING? NO THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE CUT BUT DID NOT STAPLE CORRECTLY. THE STAPLES WERE MALFORMED. AN ENDOLOOP WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
490066	ETS LINEAR CUTTER	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	L4EJ83

Patients

Seq	Age	Sex	Outcome	Treatment
1				RELOAD - 6R45B