BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL, CUTTING & COAGULATION REPROCESSED

    MDR report key: 5068274 · Received September 10, 2015

    Report

    Report Number
    2134070-2015-00045
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 17, 2015
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K143260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT AFTER THE DEVICE EVALUATION IF THE DEVICE IS RECEIVED. NO LOT NUMBER WAS REPORTED SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE SURGEON WAS COMPLAINING ABOUT THE FUNCTIONALITY OF THE DEVICE. UPON REQUEST FOR ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE GRASPER WAS STICKY AND DIFFICULT TO REMOVE FROM TISSUE THAT IT HAD BEEN USED ON. IT WAS ALSO REPORTED THAT THE DEVICE JAWS WERE STICKING TO TISSUE. THERE WAS NO PATIENT INJURY OR HARM. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599059 ELECTROSURGICAL, CUTTING & COAGULATION REPROCESSED NUJ STERILMED, INC. COVLF1637

    Patients

    Seq Age Sex Outcome Treatment
    1