BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC CHOLECYSTECTOMY KIT

    MDR report key: 5270146 · Received December 7, 2015

    Report

    Report Number
    5270146
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Date of Event
    September 1, 2015
    Report Date
    November 19, 2015
    Manufacturer
    LEESAR, INC.
    Product Code
    PKE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVER A PERIOD OF TIME, OUR OPERATING ROOM STAFF HAVE IDENTIFIED INCORRECT SPONGE COUNTS RIGHT OUT OF THE PACKAGE. WE HAVE BEEN REPORTING THEM VIA MEDSUN. OUR CUSTOM SURGICAL PACK OPERATIONS COMPANY ASKED FOR A MEETING REGARDING OUR PROBLEMS WITH SPONGE COUNTS AND WE DID SO THIS MONTH. THEY EXPLAINED QUITE IN DETAIL WHAT THEY HAVE BEEN DOING FOR THE LAST FEW MONTHS TO MITIGATE THIS PROBLEM. IN SUMMARY, OUR VENDOR PUTS TOGETHER THE PACKS, OPENS THE SPONGE PACKS RECEIVED FROM THE MANUFACTURER AND COUNTS TWICE ON THEIR ASSEMBLY LINE. ONE PERSON COUNTS, THEN IT GOES TO THE NEXT PERSON TO COUNT. OUR OPERATING ROOM STAFF EDUCATORS HAVE SHARED THIS WITH OUR STAFF; OUR COUNTS ARE DONE BY LAYING OUT THE SPONGES SEPARATELY ON A FLAT SURFACE. AT THIS TIME, WE ARE SEEING FEWER INCIDENCES OF INCORRECT NUMBERS OF SPONGES IN PACKS AND WE HOPE THE PROBLEMS HAVE BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802421 LAPAROSCOPIC CHOLECYSTECTOMY KIT LAPAROSCOPIC CHOLECYSTECTOMY KIT PKE LEESAR, INC. LSRHHLAPCHC

    Patients

    Seq Age Sex Outcome Treatment
    1