PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM

MDR report key: 2870874 · Received December 12, 2012

Report

Report Number: 3005075853-2012-05650
Event Type: Malfunction
Date Received: December 12, 2012
Date of Event: December 4, 2012
Report Date: December 6, 2012
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K020779
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE GASTRECTOMY PROCEDURE, THE SURGEON CLOSED THE CLOSING HANDLE AND THEN CLOSED THE FIRING HANDLE TO COMPLETE THE FIRE. THE SURGEON MADE THE TRANSECTION UNAWARE THAT NO STAPLES DEPLOYED. THE SURGEON OVER SEWED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1