FDA Adverse Event Malfunction Summary report: N

PROXIMATE

MDR report key: 1960016 · Received December 15, 2010

Report

Report Number
1960016
Event Type
Malfunction
Date Received
December 15, 2010
Date of Event
December 14, 2010
Report Date
December 15, 2010
Manufacturer
ETHICON ENDO-SURGERY, INC.
Product Code
GDW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MT, US

Narratives

Description of Event or Problem · 1

DURING POSTEROLATERAL THORACOTOMY, THE RIBS WERE SPREAD, PLEURAL SPACE INSPECTED, WE THEN TOOK DOWN THE INFERIOR PULMONARY LIGAMENT AND OPENED THE PARIETAL PLEURA ON EITHER SIDE OF HILUM. INFERIOR PULMONARY VEIN WAS TAKEN WITH A STAPLER. WE THEN ENTERED THE FISSURE AND IDENTIFIED THE PULMONARY ARTERY BRANCHES GOING TO THE SUPERIOR SEGMENT OF LOWER LOBE & INFERIOR SEGMENTS OF LOWER LOBE. BRANCH GOING TO SUPERIOR SEGMENT WAS TAKEN W/A STAPLER. WE THEN PLACED A STAPLER ON THE BRANCHES GOING TO LOWER LOBE MAKING SURE WE DID NOT TAKE BRANCH GOING TO LINGULA. WE APPLIED THE STAPLER, BUT THE STAPLER MISFIRED AND LEFT A HOLE IN THE PULMONARY ARTERY HERE. WE PLACED CLAMPS PROXIMALLY AND DISTALLY, BUT DID LOSE SOME BLOOD AT THIS POINT. WE TRANSECTED THE PULMONARY ARTERY AND OVER SEWED BOTH CUT ENDS W/PROLENE SUTURE. CLAMPS REMOVED AND WE HAD ADEQUATE HEMOSTASIS. WE THEN DISSECTED OUT THE 2 MAIN BRONCHIAL BRANCHES GOING TO LOWER LOBE. THESE WERE THEN CLAMPED W/STAPLER. WE INFLATED THE LEFT LUNG AND MADE SURE THE LEFT UPPER LOBE INFLATED FULLY AND THAT NO AIR WAS GOING TO THE LOWER LOBE. ONCE THIS WAS INSURED, WE DEFLATED THE LEFT UPPER LOBE AND FIRED THE STAPLER. THE BRONCHUS WAS EXCISED W/STAPLER. THE FISSURE WAS TAKEN W/STA0PLERS AND THE LUNG WAS REMOVED AND PASSED OFF THE FIELD AS SPECIMEN, CLOSED, PATIENT EXTUBATED, AND TRANSFERRED TO ICU IN GUARDED CONDITION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROXIMATE STAPLER,SURGICAL GDW ETHICON ENDO-SURGERY, INC. TX30V E4L53A
2 PROXIMATE STAPLER,RELOAD, SURGICAL GDW ETHICON ENDO-SURGERY, INC. XR30V F4PK7D

Patients

Seq Age Sex Outcome Treatment
1 73 YR