BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASIX ST MESH W/ ECHO 2

    MDR report key: 11934452 · Received June 3, 2021

    Report

    Report Number
    1213643-2021-20136
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BARD SHANNON LIMITED -3005636544
    Product Code
    OWT
    PMA / PMN Number
    K182008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THIS WAS A USE OF DEVICE ISSUE WITH NO MALFUNCTION OF THE DEVICE. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. PER THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, ¿VISUALIZATION MUST BE MAINTAINED THROUGHOUT THE COURSE OF THE ENTIRE SURGICAL PROCEDURE. ADDITIONALLY, LAPAROSCOPIC REMOVAL OF THE ECHO 2¿ POSITIONING SYSTEM FRAME MUST BE PERFORMED UNDER SUFFICIENT VISUALIZATION OF THE ENTIRE DEVICE AND SURROUNDING ANATOMY, TO ENSURE PROPER REMOVAL. MAINTAIN CONSTANT VISUALIZATION AND ENSURE NO TISSUE OR ORGANS ARE CAUGHT WHILE REMOVING THE FRAME THROUGH THE TROCAR.¿ SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. NOT RETURNED - REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AS REPORTED, DURING A LAPAROSCOPIC VENTRAL INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 USING A BARD/DAVOL PHASIX ST MESH W/ECHO 2 POSITIONING SYSTEM, THE SURGEON WAS EXPERIENCING RESISTANCE WHEN ATTEMPTING TO REMOVE THE ECHO 2 PS FRAME THROUGH THE TROCAR. AFTER PULLING MULTIPLE TIMES AND MEETING RESISTANCE, THE SURGEON IDENTIFIED THAT THE BOWEL WAS BEING PULLED AND NOT THE FRAME. AS THE BOWEL AND FRAME HAD BECOME ENTANGLED, THE SURGEON UNTANGLED THE FRAME AND REMOVED IT. DUE TO THE BOWEL INVOLVEMENT, THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION AND THEN DISCHARGED HOME THE FOLLOWING DAY. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825537 PHASIX ST MESH W/ ECHO 2 SURGICAL MESH OWT BARD SHANNON LIMITED -3005636544 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other