BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4162647 · Received July 16, 2014

    Report

    Report Number
    2134070-2014-00136
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K052299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH ONE OF THE SUTURE STAYS ON THE STABILITY CONE DETACHED AND RETURNED WITH THE DEVICE. UPON EXAMINATION UNDER MAGNIFICATION, IT WAS FOUND THAT ONE OF THE LOCKING TABS ON THE SUTURE STAY HAD BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. IT ALSO WAS NOTED THAT THERE WAS A CRACK INSIDE THE SLEEVE AND ON THE STOPCOCK. THE DEVICE SLEEVE WAS THEN PRESSURE TESTED FOR LEAKING. THE SLEEVE SHOWED NO SIGNS OF LEAKING WHEN TESTED BY ITSELF, BUT DID SHOW SIGNS OF LEAKING WHEN AN OBTURATOR WAS INSERTED INTO THE SLEEVE. NO LOT NUMBER WAS PROVIDED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE LEAKED. THE "PART OF THE TROCAR THAT SUTURE IS TIED TO BROKE OFF AND WAS RETRIEVED," ANOTHER DEVICE OPENED. IT APPEARED THAT THE DEVICE BROKEN WHEN THE TUBING WAS CONNECTED. THE PROCEDURE WAS PAUSED WHILE THE PARTS OF THE DEVICE WERE RETRIEVED, BUT NO PIECES OF THE DEVICE FELL INTO THE PATIENT. THERE WAS NO ALTERATION IN THE OUTCOME, AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416270 NA NLM - ENDOSCOPIC TROCAR NLM STERILMED, INC. ETHH12LP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR