BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE

    MDR report key: 1821128 · Received August 30, 2010

    Report

    Report Number
    3006119098-2010-00002
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    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
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SURGEON WAS BEGINNING A RADICAL NECK DISSECTION WHEN A (B)(4) HEMOSTATIX SCALPEL BLADE DEVELOPED A SHORT BETWEEN THE TWO CIRCUITS THICK-FILMED ON ONE SIDE GENERATING A BRIEF "SPARK" WHICH STARTLED THE USER. NEITHER THE PT NOR THE USER WAS INJURED; HOWEVER, THE SURGEON WAS "STARTLED" AND DECIDED NOT TO USE THE INSTRUMENT.

    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 7013-5715 HMT0553

    Patients

    Seq Age Sex Outcome Treatment
    1