FDA Adverse Event Malfunction Summary report: N

ECHELON*FLEX60 LONG

MDR report key: 1905836 · Received November 23, 2010

Report

Report Number: 3005075853-2010-06662
Event Type: Malfunction
Date Received: November 23, 2010
Date of Event: November 1, 2010
Report Date: November 1, 2010
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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. EES ENGINEER AND PRODUCT DIRECTOR MET WITH THE SURGEON TO OBSERVE A CASE AND DISCUSS SURGICAL TECHNIQUE AND CARTRIDGE SELECTION.

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.DEVICE NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE WAS FIRED WITH THE FIRST WHITE LOAD ACROSS THE JEJUNUM AND THE STAPLE LINE APPEARED INTACT. TOWARDS THE END OF THE CASE THE SURGEON NOTICED A LOT OF BLOOD AROUND THE OMENTUM. THE BILIOPANCREATIC LIMB AT THE JEJUNO-JEJUNOSTOMY. THERE WERE MALFORMED STAPLES. THERE WAS ALSO ONE MALFORMED STAPLE FOUND AT THE ROUX LIMB END. THE STAPLE LINE WAS THEN TRANSECTED AND ANOTHER RELOAD WITH SEAM GUARD WAS USED TO REPAIR THE STAPLE LINE. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. NO BLOOD TRANSFUSION WAS GIVEN. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ECHELON*FLEX60 LONG	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	G4TD3T

Patients

Seq	Age	Sex	Outcome	Treatment
1				RELOADS - (B)(4)