BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE, REPROCESSED

    MDR report key: 4152556 · Received October 6, 2014

    Report

    Report Number
    2134070-2014-00176
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 11, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER'S FACILITY AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE FILED AFTER INVESTIGATION IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST CLIP CAME OUT CRIMPED BEFORE EVENT BEING PLACED ON THE VESSEL. THEN WHEN TRYING TO USE IT AGAIN, IT KEPT SPITTING OUT AN EXTRA CLIP. THERE WAS NO PATIENT INJURY. IT WAS LATER REPORTED THAT THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY. THE "CRIMPED" CLIP WAS CROSSED. THE EXTRA CLIPS COMING OUT OF THE DEVICE WERE NOT UNFORMED. THE ISSUE OCCURRED WHEN FIRING OVER THE CYSTIC DUCT. THERE WAS NO RESISTANCE FELT WHEN FIRING THE DEVICE . THE DEVICE WAS TRIED A SECOND TIME AND THE CLIPS WERE CROSSED. THE DEVICE WAS REPLACED WITH A DEVICE FROM ANOTHER MANUFACTURER. THE PROCEDURE WAS PROLONGED, BUT NO TIME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622136 CLIP, IMPLANTABLE, REPROCESSED NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1