BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON LINEAR STAPLER LOAD

    MDR report key: 2792350 · Received October 12, 2012

    Report

    Report Number
    2792350
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    July 18, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING A LAPAROSCOPIC SLEEVE GASTRECTOMY USING AN ETHICON ECHELON LINEAR STAPLER WITH AN ECR60G LOAD (LOT NUMBER UNKNOWN). THE STAPLES WERE RELEASED FROM THE LOAD BUT SOME OF THE STAPLES DID NOT FORM CORRECTLY, RESULTING IN A DEFECT IN THE STAPLE LINE. DR THEN USED A SECOND LOAD WITH THE SAME STAPLER TO CORRECT THE DEFECT WITHOUT INCIDENT. DR DID AN EGD (ESOPHAGOGASTRODUODENOSCOPY) ON THE PATIENT IN THE OPERATING ROOM TO CHECK THE INTEGRITY OF THE STAPLE LINE PER HIS USUAL ROUTINE. THERE WAS NO IMMEDIATE HARM TO THE PATIENT."WE HAD 1 STAPLER MISFIRED, BUT WE WERE ABLE TO CORRECT IT.THE SECOND FIRE WHERE THERE WAS NO EVIDENCE OF CRACKED STAPLE, WE NOTED THE IT DID NOT FORM STAPLE LINE AT ALL AND WAS OPENING. I CAN SEE IT AND THEN THE STAPLE DID NOT FORM V SHAPE AT ALL. WE HAVE TO RESECT THIS STAPLE LINE THAT WAS UNFORMED. WE WERE ABLE TO USE THE SAME GUN. I AM NOT SURE WHAT WENT AS A PROBLEM WITH THE CARTRIDGE OR WHAT. WE WERE ABLE TO CORRECT THIS DEFECT WITHOUT DIFFICULTY NOT COMPROMISING THE LUMEN" AS PER SURGEON'S OPERATION NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON LINEAR STAPLER LOAD STAPLER, LOAD, SURGICAL GDW ETHICON ENDO SURGERY, INC. ETHICON BLUE RELOAD *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR