BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIDAC

    MDR report key: 6053488 · Received October 25, 2016

    Report

    Report Number
    6053488
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 14, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 2-0 SURGIDAC WAS OPENED TO THE SURGICAL FIELD. WHEN THE TECH WENT TO LOAD THE SURGIDAC ON THE ENDO STITCH APPLIER, THE SUTURE ITSELF DID NOT LINE UP PROPERLY WITH THE APPLIER AND COULD NOT BE LOADED. THE TECH AND SURGEON BOTH COULD NOT LOAD IT PROPERLY. THREE 2-0 SURGIDAC PACKAGES WHERE OPENED AND THIS HAPPENED SIX OUT OF THE SEVEN TIMES. THE REF NUMBER FOR ALL THREE WAS (B)(4), AND EXP DATE FOR ALL WERE 2021-01. EVENT INVESTIGATED WITH OR RN AND SURGICAL TECH. IT WAS NOT THE ENDO STITCH APPLIER THAT WAS FAULTY BUT THE SURGIDAC SUTURE PACKS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THEY OPENED A DIFFERENT SUTURE THAN THE SURGIDAC AND THAT WORKED AND WAS NOT A PROBLEM. THE OR WAS SEARCHED AND WE DID NOT HAVE ANY ADDITIONAL SUTURE WITH THE AFFECTED LOT NUMBER. THERE WAS LITTLE DELAY IN THE CASE. THE SUTURE PACKAGING WAS NOT KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704570 SURGIDAC SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE GAR COVIDIEN 2-0 SURGIDAC J6A1971X (X2), J6A1459X (X1)

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR