BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE

    MDR report key: 1435105 · Received August 10, 2009

    Report

    Report Number
    3006119098-2009-00001
    Event Type
    Injury
    Date Received
    August 10, 2009
    Date of Event
    July 29, 2009
    Report Date
    August 5, 2009
    Manufacturer
    HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
    Product Code
    GEI
    PMA / PMN Number
    K902307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING A BLADE INTO A HANDLE, THE SURGICAL TECH (JC) WRAPPED THE BLADE IN A SURGICAL TOWEL. THE TECH WRAPPED HER HAND AROUND THE TOWEL AND TRIED TO INSERT THE BLADE AT WHICH TIME THE BLADE CUT THROUGH THE TOWEL, AND INTO HER HAND. THE RESULTING INJURY REQUIRED 4 STITCHES TO CLOSE. THE SURGICAL TECH REPORTED TO REPORTER OF THIS EVENT, THAT SHE CONSIDERED IT TO BE USER ERROR AND NOT THE FAULT OF THE DEVICE.

    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 5715 HMT0353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other