BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 797756 · Received December 14, 2006

    Report

    Report Number
    1221941-2006-00002
    Event Type
    Malfunction
    Date Received
    December 14, 2006
    Report Date
    June 27, 2006
    Manufacturer
    MEDICAL AND SCIENTIFIC ENTERPRISES, INC.
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING MEDICAL SCIENTIFIC EVALUATION, IT WAS FOUND THE UNIT HAD HIGH BIPOLAR OUTPUT. THE UNIT REQUIRED CALIBRATION FOR THE BIPOLAR OUTPUT. A SNARE USED DURING EVENT IS A MONOPOLAR DEVICE. THE MONOPOLAR OUTPUT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE UNIT PASSED ALL OTHER VISUAL, MECHANICAL, AND ELECTRICAL EVALUATIONS. ALL REQUIRED CALIBRATIONS WERE COMPLETED, THEN THE UNIT WAS RETESTED. THE UNIT WAS FOUND TO MEET ALL SPECIFICATIONS AND WAS SENT BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THROUGH A REQUEST FOR REPAIR THAT WHILE USING AN ENDOSTAT II ELECTROSURGICAL POWER GENERATOR DURING AN UNKNOWN PROCEDURE WITH A SNARE DEVICE (SNARE TYPE AND DATE OF PROCEDURE ARE UNKNOWN), THE ALARMS SOUNDED INTERMITTENTLY AND THE TIP OF THE SNARE JOLTED THE PATIENT UPON CONTACT. THE PHYSICIAN CHANGED THE GROUNDING PADS AND THE SNARES BUT THE INTERMITTENT ISSUES PERSISTED. NO PATIENT INJURY OR ILL EFFECTS WERE REPORTED AS A RESULT OF THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT KNS KNS MEDICAL AND SCIENTIFIC ENTERPRISES, INC. M0054080R0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other