BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB 20

    MDR report key: 947063 · Received October 26, 2007

    Report

    Report Number
    947063
    Event Type
    Injury
    Date Received
    October 26, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 24, 2007
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OVER THE PAST MONTH OR SO, APPROXIMATELY SIX CASES OF BROKEN SUTURE LINE HAVE BEEN REPORTED. IT WAS INVESTIGATED AND DETERMINED THAT ONE RESULTED IN A RETURN TO OR DUE TO LEAKING. IN ADDITION, AFTER DISCUSSION WITH STAFF AND PHYSICIANS IT WAS NOTED THAT NUMEROUS EVENTS OF SUTURE LINE BREAKING DURING SURGERY OCCURRED AND SIMPLY WERE NOT REPORTED AS THE PHYSICIAN WAS ABLE TO RESUTURE WHILE THE PATIENT WAS STILL OPEN. COMPANY INDICATES THAT THEY BELIEVE THAT THE PRODUCT WAS COMPROMISED DURING TRANSPORT AT EXTREMELY HIGH TEMPERATURES. RECORDS INDICATE THAT THE NEED TO VERIFY TEMPERATURE INDICATOR WAS NOT PROVIDED ON PURCHASE AND THAT THE SUTURE IS REMOVED FROM THE BOX WITH THE INDICATOR ON IT AT OUR WAREHOUSE AND STORED; THEREFORE, NO CHECK OF THE TEMPERATURE INDICATOR WAS BEING DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB 20 STAPLER, SKIN GDT INCISIVE SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| R NONE TO MY KNOWLEDGE| NONE TO MY KNOWLEDGE