BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIDAC

    MDR report key: 6401963 · Received March 14, 2017

    Report

    Report Number
    6401963
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 9, 2017
    Manufacturer
    COVIDIEN LP
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, SURGICAL TECH TRIED TO LOAD 2-0 ENDO-STITCH FROM A MULTI-PACK INTO SUTURING DEVICE. THE ENDO-STITCH WOULD NOT LOAD CORRECTLY. A NEW PACK WAS OPENED TO CONCLUDE THE CASE, AND THE DEFECTIVE ENDO-STITCH WAS GIVEN TO THE CLINICAL ENGINEERING DEPARTMENT. NO HARM CAME TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PER SITE REPORTER, THE MANUFACTURER WILL BE ISSUING A RETURN KIT. WE WILL RETURN THE DEVICE FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185780 SURGIDAC ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN LP 170044 J6B1041X

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR