ECHELON 60

MDR report key: 2082186 · Received May 9, 2011

Report

Report Number: 3005075853-2011-01867
Event Type: Malfunction
Date Received: May 9, 2011
Date of Event: April 13, 2011
Report Date: April 13, 2011
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): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative · 1

(B)(4). THE EC60 DEVICE WAS RETURNED WITH TWO RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED. THE VISUAL INSPECTION SHOWED THAT A 3-STROKE INDICATOR DISK WAS DAMAGED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE FUNCTIONAL TEST DEMONSTRATED THE DEVICE FIRED, CUT AND FORMED ALL STAPLES AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE INDICATOR DISK BECAME BROKEN, PLEASE NOTE THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT'S BODY THROUGH THE RIGHT SIDE OF ABDOMINAL PORT AND FIRED AT THE FIRST FIRING. A FEW STAPLES WHICH WERE DEPLOYED ON THE ELEMENTARY 1 CM PART OF ONE SIDE OF THE STAPLE LINE WERE UNFORMED. A FEW UNFORMED STAPLES WERE DEPLOYED ON THE ANUS SIDE. REINFORCEMENT PRODUCT WAS NOT USED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ECHELON 60	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	G4U651

Patients

Seq	Age	Sex	Outcome	Treatment
1				(B)(4), LOT#- G4UG5C