ECHELON*FLEX60

MDR report key: 1972889 · Received January 28, 2011

Report

Report Number: 3005075853-2011-00338
Event Type: Malfunction
Date Received: January 28, 2011
Date of Event: January 4, 2011
Report Date: January 7, 2011
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K081146
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS FOUND THAT ONE SC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE EC60B CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, WHEN THE DEVICE WAS USED TO CUT THE RECTUM AT THE FIRST FIRING, THE STAPLES WERE MALFORMED. THE STAPLES SHAPE SEEMED TO LUMBRICOID-SHAPE. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED THAT THE FIRST STROKE HAD BEEN VERY HARD, BUT THE SECOND AND THIRD STROKES HAD BEEN VERY LIGHT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ECHELON*FLEX60	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	G4U23Z

Patients

Seq	Age	Sex	Outcome	Treatment
1				ECR60B, (B)(4)