BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURE SET SURGICAL SET-UP

    MDR report key: 1032480 · Received April 14, 2008

    Report

    Report Number
    1417592-2008-00008
    Event Type
    Other
    Date Received
    April 14, 2008
    Report Date
    April 11, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# 06JB0509. IT WAS REPORTED THAT THE CAUTERY PENCIL DID NOT TURN OFF, AND WAS PLACED DOWN ON A PATIENT RATHER THAN PLACING IT IN ITS HOLSTER. IT CAUSED A MINOR BURN. IT WAS REPORTED THAT NO FOLLOW UP CARE WAS INDICATED FOR THE BURN BUT THE REPORTER THOUGHT THAT THE BURN HAD BEEN EXCISED. THREE CAUTERY PENCIL SAMPLES WERE RETURNED AND EVALUATED. TWO OF THE SAMPLES APPEARED TO BE WIPED CLEAN. DRIED BLOOD COULD BE SEEN ON THE CASE SEAMS AND AROUND THE BUTTONS. THE THIRD SAMPLE WAS VERY BLOODY AND HAD BLOOD STAINS OVER THE ENTIRE PENCIL. THE CORD HAD BEEN CUT ON THIS THIRD SAMPLE PRIOR TO ITS RETURN TO US. THE TWO PENCILS THAT HAD A NON-CUT CORD WERE ACTIVATED IN BOTH THE CUT AND COAG MODES AT A SETTING OF 40 FOR 10 SECONDS, 10 TIMES AND THE PENCIL PERFORMED NORMALLY WITH NO MALFUNCTIONS. THERE WAS NO OCCURRENCE OF STICKING AND THE TACTICLE FEEDBACK OF THE BUTTON APPEARED TO BE NORMAL. BASED UPON THE SAMPLE EVALUATIONS, WE COULD NOT CONFIRM THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THEIR CAUTERY PENCILS DID NOT ALWAYS TURN OFF. ONE CAUTERY PENCIL WAS STILL ON AND WAS PLACED DOWN ONTO A PATIENT. PATIENT SUFFERED A SMALL BURN TO THE NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE SET SURGICAL SET-UP NONE LRO MEDLINE INDUSTRIES, INC. DYNJS0160 07AB2926

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other