BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM RETRIEVAL SYSTEM

    MDR report key: 3830359 · Received May 23, 2014

    Report

    Report Number
    2027111-2014-00252
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    August 27, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SIX (6) UNOPENED UNITS FROM THE SAME LOT AS THE EVENT UNITS WERE RETURNED FOR EVALUATION. IN THE ABSENCE OF THE ACTUAL SUBJECT DEVICES, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENTS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT REVEALS THE LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. ENGINEERING TESTED THREE OF THE RETURNED UNOPENED UNITS AND ATTEMPTED TO REPLICATE THE INCIDENTS; HOWEVER, THE INCIDENTS WAS UNABLE TO BE REPLICATED UNDER NORMAL CONDITIONS. APPLIED MEDICALS INSTRUCTION FOR USE (IFU) STATES, "CARE SHOULD BE TAKEN TO AVOID CONTACT OF THE BAG WITH SHARP INSTRUMENTS, MORCELLATORS, CUTTING DEVICES, AND ELECTROSURGICAL AND LASER INSTRUMENTS." ADDITIONALLY, "IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE PORT SITE FOR EASE OF BAG REMOVAL." THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    LAP CHOLE - "DOCTOR USES AN ALL 5 SOLUTION, UPON REMOVAL OF GALLBLADDER THE STRING BROKE LEAVING BAG AND SPECIMEN INSIDE PATIENT. A SECOND BAG WAS USED AND IT TORE. SPECIMEN WAS REMOVED WITH GRASPERS, ALONG WITH BAG." PATIENT STATUS- "NO ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308017 5MM RETRIEVAL SYSTEM TISSUE EXTRACTION BAG; CODE:GCJ GCJ APPLIED MEDICAL CD003 1202688

    Patients

    Seq Age Sex Outcome Treatment
    1