BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT PLUS

    MDR report key: 10710626 · Received October 21, 2020

    Report

    Report Number
    9680952-2020-00041
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 21, 2020
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    UDI-DI
    05051986002347
    PMA / PMN Number
    K070712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE SEE ATTACHED COMPLAINT INVESTIGATION REPORT FOR DETAILS UPDATE FOR THIS SUBMISSION TO NOTE THAT THE FINAL REPORT WAS SUBMITTED ON THE 30TH NOVEMBER 2020 BUT WAS NOT IDENTIFIED UNTIL 20TH OCTOBER 2021 THAT THE FINAL SUBMISSION REPORT HAD NOT BEEN SUCESSFUL.

    Description of Event or Problem · 0

    BEFORE THE LAP PROCEDURE, NURSE OPENED THE PACKAGE AS USUAL AND CHECKED THE VALVE BRIEFLY. HOWEVER, AFTER THE PROCEDURE COMPLETED, THE NURSE DISSEMBLED THE REUSABLE AND DISPOSABLE PARTS OF TROCAR, SHE FOUND THERE WAS MISSING PORTION ON THAT VALVE AND THEY COULDN'T FIND IT ANYWHERE.

    Description of Event or Problem · 1

    BEFORE THE LAP PROCEDURE, NURSE OPENED THE PACKAGE AS USUAL AND CHECKED THE VALVE BRIEFLY. HOWEVER, AFTER THE PROCEDURE COMPLETED, THE NURSE DISSEMBLED THE REUSABLE AND DISPOSABLE PARTS OF TROCAR, SHE FOUND THERE WAS MISSING PORTION ON THAT VALVE AND THEY COULDN'T FIND IT ANYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180448 YELLOPORT PLUS 5MM SINGLE USE DUCKBILL VALVE GCJ SURGICAL INNOVATIONS LTD YA05VSS01 730585 05051986002347

    Patients

    Seq Age Sex Outcome Treatment
    1