BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLINGTON LAP

    MDR report key: 2270588 · Received September 15, 2011

    Report

    Report Number
    1056591-2011-00002
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    SRI/ SURGICAL EXPRESS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INSTRUMENT SET/CONTAINER WAS RETURNED TO SRI/SURGICAL EXPRESS, INC. FOR DECONTAMINATION, STERILIZATION AND PACKAGING, THERE WERE NO BOTTOM FILTERS OR RETENTION PLATES PRESENT.

    Description of Event or Problem · 1

    A CONCLUSION OF A PROCEDURE, THE INSTRUMENT TRAY USED AND IT'S RIGID STERILIZATION CONTAINER WERE MOVED TO THE STERILE PROCESSING DEPARTMENT AT WHICH TIME THE HOSPITAL DISCOVERED THAT THE CONTAINER WAS MISSING THE STERILIZATION FILTERS IN THE BOTTOM OF THE CONTAINER AS WELL AS THE RETENTION PLATES THAT HOLD THE FILTERS IN PLACE. THE FILTERS COVER HOLES IN THE BOTTOM OF THE RIGID CONTAINER WHICH ALLOW STEAM TO PENETRATE THE TRAY AND PROVIDE A STERILE BARRIER. AFTER REVIEW OF THE SITUATION BY THE HOSPITAL'S INFECTION CONTROL AND RISK MANAGEMENT, IT WAS DETERMINED TO BE OF LOW RISK, AND NO ADDITIONAL MEDICAL MEDICATION WAS GIVEN TO THE PATIENT. NO ADVERSE EVENT HAS BEEN REPORTED AT THIS TIME.

    Additional Manufacturer Narrative · 2

    WHEN THE INSTRUMENT SET/CONTAINER WAS RETURNED TO SRI/SURGICAL EXPRESS, INC. FOR DECONTAMINATION, STERILIZATION AND PACKAGING, THERE WERE NO BOTTOM FILTERS OR RETENTION PLATES PRESENT.

    Description of Event or Problem · 2

    A CONCLUSION OF A PROCEDURE, THE INSTRUMENT TRAY USED AND IT'S RIGID STERILIZATION CONTAINER WERE MOVED TO THE STERILE PROCESSING DEPARTMENT AT WHICH TIME THE HOSPITAL DISCOVERED THAT THE CONTAINER WAS MISSING THE STERILIZATION FILTERS IN THE BOTTOM OF THE CONTAINER AS WELL AS THE RETENTION PLATES THAT HOLD THE FILTERS IN PLACE. THE FILTERS COVER HOLES IN THE BOTTOM OF THE RIGID CONTAINER WHICH ALLOW STEAM TO PENETRATE THE TRAY AND PROVIDE A STERILE BARRIER. AFTER REVIEW OF THE SITUATION BY THE HOSPITAL'S INFECTION CONTROL AND RISK MANAGEMENT, IT WAS DETERMINED TO BE OF LOW RISK, AND NO ADDITIONAL MEDICAL MEDICATION WAS GIVEN TO THE PATIENT. NO ADVERSE EVENT HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLINGTON LAP LAPAROSCOPIC INSTRUMENT SET/CONTAINER GCJ SRI/ SURGICAL EXPRESS, INC. 320399001

    Patients

    Seq Age Sex Outcome Treatment
    1
    2