BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORBAFIX

    MDR report key: 2859752 · Received December 4, 2012

    Report

    Report Number
    2859752
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    DAVOL, A BARD COMPANY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN UNDERGONE LAPAROSCOPIC PARASTOMAL REPAIR THREE DAYS EARLIER. THE PATIENT HAD NO STOMA OUTPUT AND CT SCAN WAS OBTAINED DUE TO WORSENING DISTENTION OF THE ABDOMEN. THE PATIENT HAD A LOOP OF SMALL INTESTINE THAT WAS ADHERED IN HER PELVIS ON CT SCAN, WHICH WAS CONCERNING FOR A CLOSED LOOP OBSTRUCTION AND THEREFORE IT WAS ELECTED TO EXPLORE THE PATIENT. IT WAS ELECTED TO TAKE DOWN THE CURRENT PIECE OF MESH IN ORDER TO INSPECT THE VERY DISTAL PORTION OF THE ILEUM AND ILEOSTOMY. ONCE THE MESH HAD BEEN REMOVED, IT WAS WASHED OFF WITH SALINE. WE BROUGHT IT BACK INTO THE FIELD AFTER THE CLOSED PARASTOMAL HERNIA WAS INSPECTED. THIS APPEARED TO BE WITHOUT ANY ABNORMALITIES. THEREFORE, THE MESH WAS PLACED AROUND THE ILEUM. THE SURGEON TRIED TO DEPLOY THE SORBAFIX, BUT THE DEVICE WOULD NOT DRIVE THE FASTENERS THROUGH THE MESH INTO THE TISSUE. THE SURGEON REMOVED THE SORBAFIX, OBTAINED ANOTHER DEVICE, AND COMPLETED THE FIXATION OF THE MESH TO THE TISSUE. PATIENT WENT TO RECOVERY IN STABLE CONDITION WITHOUT ANY UNTOWARD EFFECTS. SURGEON COMPLAINED TO CIRCULATING NURSE THAT THE SORBAFIX ABSORBABLE FIXATION SYSTEM FAILS TO FASTEN ALL THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORBAFIX STAPLER, IMPLANTABLE GDW DAVOL, A BARD COMPANY 0113116 HUWB0639

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR