BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT PLUS

    MDR report key: 7709657 · Received July 23, 2018

    Report

    Report Number
    9680952-2018-00002
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    June 21, 2018
    Report Date
    July 23, 2018
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    UDI-DI
    05051986002347
    PMA / PMN Number
    070712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE DOCTOR CONFIRMED AIR LEAKAGE AND THE VALVE WAS DAMAGED. IT HAPPENED 5MINS AFTER THE BEGINNING OF SURGERY. HE/ SHE USED A GRASPING FORCEPS AND INSERTED JUST ONCE. THE USER COULD NOT FIND THE BROKEN PARTS. DURING A PROCEDURE, THE DOCTOR CONFIRMED AIR LEAKAGE AND THE VALVE WAS DAMAGED. IT HAPPENED 5MINS AFTER THE BEGINNING OF SURGERY. HE/ SHE USED A GRASPING FORCEPS AND INSERTED JUST ONCE. THE USER COULD NOT FIND THE BROKEN PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551930 YELLOPORT PLUS 5MM SINGLE USE DUCKBILL VALVE GCJ SURGICAL INNOVATIONS LTD YA05VSS01 712796 05051986002347

    Patients

    Seq Age Sex Outcome Treatment
    1