FDA Adverse Event Injury Summary report: N

ENDO GIA

MDR report key: 6924917 · Received October 6, 2017

Report

Report Number
1219930-2017-07801
Event Type
Injury
Date Received
October 6, 2017
Date of Event
September 5, 2017
Report Date
September 9, 2017
Manufacturer
COVIDIEN LP LLC NORTH HAVEN
Product Code
GDW
PMA / PMN Number
K111825
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
HEALTH PROFESSIONAL

Narratives

Description of Event or Problem · 1

ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT AN OPEN SMALL BOWEL RESECTION PROCEDURE. THE PATIENT'S MEDICAL HISTORY IS NEUROENDOCRINE TUMOR. THE STAPLING DEVICE WAS BEING USED TO CREATE A SMALL BOWEL SIDE BY SIDE ANASTOMOSIS. DURING THE PROCEDURE IT LOOKED HEMOSTATIC. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE SMALL BOWEL HAD AN ANASTOMOTIC BLEED THAT REQUIRED THE PATIENT TO BE TAKEN BACK TO THE OPERATING ROOM AND REVISE THE ANASTOMOSIS. THE REOPERATION OCCURRED THREE DAYS AFTER THE INITIAL PROCEDURE. THE REVISION OF THE SMALL BOWEL ANASTOMOSIS REQUIRED ADDITIONAL SMALL BOWEL TISSUE TO BE TAKEN. ON THE TAKE BACK, REVISED THE ANASTOMOSIS AND INITIALLY USED TRI STAPLE RELOAD. NOTED SOME BLEEDING FROM THE STAPLE LINE, MINIMAL, WHERE THE BOWEL WAS DIVIDED. IT WAS EASILY CONTROLLED WITH BOVIE. HOWEVER, USED UNIVERSAL RELOAD TO MAKE THE ANASTOMOSIS. IT LOOKED HEMOSTATIC TOO AFTER CREATING. ON BOTH OCCASION, CLOSED USING HAND SEW. THE PATIENT'S HGD DROPPED FROM 13 GM TO 9 GM DURING THE COURSE OF TREATMENT. THE PATIENT'S HOSPITAL STAY WAS EXTENDED BY TWO DAYS. THE CURRENT PATIENT STATUS IS GOOD. NO REINFORCEMENT MATERIAL WAS USED. THE COMMON ENTEROTOMY WAS HAND SEWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
699267 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 50 YR Hospitalization| O| R