BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM

    MDR report key: 5993255 · Received October 3, 2016

    Report

    Report Number
    5993255
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 20, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON TACKED MESH TO ABDOMINAL WALL WITH ABSORBABLE TACKS, REMOVING ECHO PS POSITIONING SYSTEM FROM TACKED MESH BY PULLING IN NORMAL FASHION. THE ECHO PS POSITIONING SYSTEM WAS DELIVERED THROUGH 12MM OPERATIVE PORT WITH LAPAROSCOPIC GRASPER. WHILE DOING, SURGEON DISCOVERED THAT A PIECE (APPROXIMATELY 4.5CM X 2CM) TORE FROM THE MAIN BODY OF THE ECHO PS POSITIONING FRAMEWORK LANDING ON MESENTERY. RETRIEVAL WAS DONE BY SURGEON IMMEDIATELY, WITH LAPAROSCOPIC INSTRUMENT. THE TORN PIECE WAS COMPARED TO THE MISSING AREA ON THE MAIN BODY OF THE POSITIONING SYSTEM(PREVIOUSLY DELIVERED) AND DETERMINED BY THE SURGEON THAT THE ENTIRE TORN PIECE WAS REMOVED SUCCESSFULLY CAUSING NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646675 VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM MESH, SURGICAL, POLYMERIC, DEPLOYMENT BALLOON OQL DAVOL INC., SUB. C.R. BARD, INC. 5955600 HHUZK0663

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR OTHER, GENERAL ANESTHESIA. UNKNOWN IF THIS WAS| PATIENT HAVING GENERAL ANESTHESIA FOR LAPAROSCOPIC