BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOL BIO-MEDICAL INSTRUMENT, INC.

    MDR report key: 1583161 · Received January 11, 2010

    Report

    Report Number
    MW5014392
    Event Type
    Injury
    Date Received
    January 11, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 11, 2010
    Manufacturer
    KOL BIO-MED INSTRUMENTS, INC.
    Product Code
    KNA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR (B) (6) WAS USING AN ACCUCIRC ON A PT WITHOUT INCIDENT UNTIL THE HANDLE WAS DEPRESSED. HE WAITED 5 MINUTES FOR HEMOSTASIS AND WHEN HE ATTEMPTED TO UNLOCK THE HANDLE IT WAS JAMMED. AS THE LOCK WOULD NOT RELEASE, THE FORESKIN WAS MANUALLY PULLED OUT OF THE DEVICE. IT APPEARED THAT THE BLADE INSIDE NEVER FIRED. THERE WAS NO HARM TO THE PT. UPON EXAMINATION BY THE KOL REP, IT APPEARS THAT THE DEVICE MAY NOT HAVE BEEN ENGAGED CORRECTLY. THE REP SPOKE WITH DR (B) (6) AND TOOK THE DEVICE WITH HIM FOR QA ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOL BIO-MEDICAL INSTRUMENT, INC. ACCUCIRC KNA KOL BIO-MED INSTRUMENTS, INC. CIRC - 1100 090910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention