FDA Adverse Event Malfunction Summary report: N

ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

MDR report key: 3113777 · Received May 15, 2013

Report

Report Number: 3005075853-2013-02342
Event Type: Malfunction
Date Received: May 15, 2013
Date of Event: March 31, 2013
Report Date: April 4, 2013
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: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE INSTRUMENT WAS RECEIVED WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60B RELOAD LOADED IN THE DEVICE. UPON FURTHER INSPECTION OF THE RELOAD, THE SLED WAS BROKEN IN THE AREA WHERE INTERACTS WITH THE KNIFE. 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. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DAMAGE TO THE ONE PIECE SLED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE ECHELON DEVICE LOCKED. NO OTHER DETAILS OF WHAT HAPPENED WITH THE DEVICE WERE REPORTED. THE DEVICE WAS CHANGED AND THE PROCEDURE COMPLETED. NO PATIENT IMPACT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
214008	ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	K4C909

Patients

Seq	Age	Sex	Outcome	Treatment
1