BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 869929 · Received June 25, 2007

    Report

    Report Number
    1221941-2007-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Date of Event
    May 31, 2007
    Report Date
    May 31, 2007
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. A VISUAL AND MECHANICAL INSPECTION REVEALED THE UNIT WAS SOUND AND IN GOOD CONDITION. AN ELECTRICAL EVALUATION FOUND THAT THE FOOTSWITCH WAS INTERMITTENT; THEREFORE, IT WAS REPLACED. THE UNIT HAS PASSED ALL FINAL TESTING AND WILL BE SHIPPED TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS RELATED TO THE PRODUCT FAMILY WAS CONDUCTED; NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN RECORDED. THE MAY 2007 15 MONTH HEMOSTASIS GENERATOR AND ACCESSORIES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007, THAT AFTER A PROCEDURE USING A REFURBISHED ENDOSTATIN ELECTROSURGICAL UNIT IN WHICH THE DEVICE HAD "INTERMITTING PROBLEMS," THE NURSE RECEIVED "A SHOCK" FROM THE FOOT PEDAL WHILE "THE NURSE AND THE DOCTOR WERE TRYING TO SEE WHAT THE ISSUE WAS WITH THE DEVICE." THE NURSE'S CONDITION IS REPORTED AS "FINE" WITH NO SUSTAINED "COMPLICATIONS OR ILL EFFECTS." NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT KNS MEDICAL SCIENTIFIC, INC. M0054080RO 1653

    Patients

    Seq Age Sex Outcome Treatment
    1 YR