FDA Adverse Event Malfunction Summary report: N

ECHELON FLEX

MDR report key: 2250778 · Received September 13, 2011

Report

Report Number
2250778
Event Type
Malfunction
Date Received
September 13, 2011
Date of Event
July 18, 2011
Report Date
September 13, 2011
Manufacturer
ETHICON ENDO-SURGERY, INC.
Product Code
GDW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US

Narratives

Description of Event or Problem · 1

CIRCULATOR ASKED ME TO GO INTO ROOM TO HELP TROUBLESHOOT THE ECHELON STAPLER. I WAS TOLD IT WAS "NOT FIRING". RESIDENT WAS HOLDING THE STAPLE GUN. SHE BEGAN PULLING THE HANDLE AND SHOWING ME WHAT SHE HAD DONE. SHE OPENED THE JAWS AND THERE WAS NO LOAD IN THE GUN (HANDLE). THEY SAID THEY HAD REMOVED IT. I SUGGESTED THE GUN MIGHT BE DEFECTIVE AND OBTAINED ANOTHER GUN. SHE AGAIN STARTED CLOSING THE STAPLER HANDLE AND PUSHING ON THE RED BUTTON; I SUGGESTED TO THE DR THAT I WOULD CALL THE REPRESENTATIVE AND HE SAID OKAY "CALL HIM". I PLACED A CALL TO THE REPRESENTATIVE AND NO ANSWER, LEFT A MESSAGE. THE DOCTOR THEN SAID HE WOULD USE "THE OTHER STAPLER". I SAID DO YOU WANT THE OTHER COMPANY'S PRODUCT? HE SAID, "YES." THE TECH RELIEVED ME AND SHE TOOK THE PRODUCT, ENDO GIA 60 VASCULAR STAPLER INTO THE ROOM. THE RESIDENT HANDLED THE STAPLER AND ATTEMPTED TO FIRE. THE DOCTOR TOLD HER TO "SQUEEZE HARDER". IT WAS AFTER FIRING AND ENGAGING THE KNIFE THAT THE TISSUE SEPARATED AND UNCONTROLLED BLEEDING BEGAN. ADDITIONAL PHYSICIANS WERE CALLED AND SCRUBBED IN. MASSIVE BLOOD TRANSFUSION PROTOCOL INITIATED. CONTROL OF BLEEDING OBTAINED AND THE DOCTORS REPAIRED THE VESSEL INJURY. SURGEON'S PLAN TO OPEN THE VAC PACK ABDOMEN AND TRANSFER POST-OP TO THE ICU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ECHELON FLEX STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. SC60A H43W53

Patients

Seq Age Sex Outcome Treatment
1 55 YR