BEUDAMED
    FDA Adverse Event Summary report: N

    SHEATH TUBE, INSULATED

    MDR report key: 3941173 · Received July 8, 2014

    Report

    Report Number
    9611102-2014-00001
    Date Received
    July 8, 2014
    Report Date
    June 4, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL INSTRUMENT WAS RETURNED TO (B)(4) ON (B)(4) /2014. THE ISOLATION ON THE SHEATH WAS BURNED. THIS DAMAGE INDICATES THE VOLTAGE SETTING WAS SET TOO HIGH ON THE HF-GENERATOR. THE INSTRUMENT WAS OPERATED OUT OF SPECIFICATION. ROOT CAUSE WAS USER ERROR. THE INCIDENT WAS REPORTED TO THE (B)(4) FROM THE MFR. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO WE WILL PROVIDE FDA WITH FOLLOW UP INFO.

    Description of Event or Problem · 1

    FROM OUR DISTRIBUTOR, (B)(4) HAS BEEN INFORMED OF A SPARK/ARC DURING A PROCEDURE. ARCING WAS OBSERVED GOING FROM THE SHEATH TO THE TROCAR. PT RECEIVED THIRD DEGREE BURN AND REQUIRED AN ADDITIONAL SURGERY. THE FOLLOWING INSTRUMENTS WERE USED IN COMBINATION DURING PROCEDURE: SHEATH (ID# (B)(4)), OLYMPUS UES-40 SURGMASTER (ID#, OLYMPUS), SETTING OF OLYMPUS UES-40 SURGMASTER: MONOPOLAR CUT 80W; COAG 60W SPRAY; GRAD BLEND (2 OF 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396660 SHEATH TUBE, INSULATED SHEATH GCJ RICHARD WOLF GMBH 8393.911 M641390

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization