FDA Adverse Event Malfunction Summary report: N

ECHELON 45

MDR report key: 1896913 · Received November 11, 2010

Report

Report Number: 3005075853-2010-06441
Event Type: Malfunction
Date Received: November 11, 2010
Date of Event: October 14, 2010
Report Date: October 14, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K051002
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): PAN. THE ANALYSIS RESULTS THAT ONE (B)(4) DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND A RELOAD PAN WAS FOUND LODGE INSIDE THE CHANNEL. THERE WAS NO CARTRIDGE RELOAD PRESENT. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGE FROM THE RELOAD, 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE, THE DEVICE WAS GOING TO BE USED FOR THE SECOND FIRING. THE DEVICE CAME OFF FROM THE INSTRUMENT BEFORE FIRING; THE DEVICE COULD NOT BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ECHELON 45	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK

Patients

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