BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE

    MDR report key: 2096243 · Received April 25, 2011

    Report

    Report Number
    3006119098-2011-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    August 3, 2010
    Report Date
    August 25, 2010
    Manufacturer
    HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
    Product Code
    GEI
    PMA / PMN Number
    K902307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED WERE TWO 7013-5710 BLADES OF UNKNOWN LOT NUMBER AND ONE 7013-8051 HANDLE OF LOT HMT0796. BOTH BLADES EXHIBITED A TRACE FAILURE ALONG THE BLADES CIRCUITRY. THE CONTROLLER WAS REPORTEDLY SET A 300 DEGREES C, WHICH IS THE MAXIMUM SETTING FOR THE CONTROLLER. THE POWER DELIVERED TO THE BLADE IS A MAXIMUM OF 60 W DC. NO AC IS DELIVERED TO THE BLADE. WE HAVE HAD ONE OTHER REPORT OF A TRACE FAILURE GENERATING A SPARK 3006119098-2010-0002). NO INJURY WAS REPORTED TO THE PATIENT OR THE USER.

    Description of Event or Problem · 1

    THE FOLLOWING WAS RECEIVED FROM OUR (B)(4) DISTRIBUTOR, (B)(4) "WE RECEIVED A COMPLAINT FROM (B)(6). OUR QA HAS INVESTIGATED SO FAR, DESCRIPTIONS ARE AS FOLLOWS: PRODUCTS: 7013-5710 TIME 2, 7013-8051 TIMES 1. REPORTED COMPLAINT; USING 8051 FOR THE 8TH TIME, WHEN BLADE WAS ENERGIZED, THERE CAME A SPARK AND THE DISPLAY MESSAGE READ "REPLACE BLADE". BLADE WAS REPLACED TO A NEW ONE, BUT THE SAME THING OCCURRED, SO DOCTOR DISCONTINUED." NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE THERMAL SCALPEL SYSTEM BLADE GEI HEMOSTATIX MEDICAL TECHNOLOGIES, LLC 7013-5710 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1