BEUDAMED
    FDA Adverse Event Other Summary report: N

    DS3.0 DISSECTING SEALER

    MDR report key: 5479906 · Received November 18, 2005

    Report

    Report Number
    1226420-2005-00005
    Event Type
    Other
    Date Received
    November 18, 2005
    Date of Event
    October 20, 2005
    Report Date
    November 2, 2005
    Manufacturer
    TISSUELINK MEDICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO IS AVAILABLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND INVESTIGATION. TLM WILL CHECK A SIMILAR DEVICE FROM A COMPARABLE LOT TO DETERMINE IF THERE IS ANY EVIDENCE OF A POSSIBLE MALFUNCTION. ADDITIONALLY TLM WILL PERFORM AN INVESTIGATION WITH A MAGNETIC MAT TO DETERMINE IF THIS WOULD AFFECT THE DEVICE IN ANY WAY. TLM REVIEWED SEVERAL LOT HISTORY RECORDS OF THE SAME PRODUCT FOR ANY SIMILAR ISSUES. NO ISSUES/FAILURES WERE FOUND. COMPONENT LOT HISTORY RECORDS WERE ALSO REVIEWED, SPECIFICALLY FOR THE CABLE ASSEMBLY. NO ISSUES/FAILURES WERE FOUND. TLM WILL CONTINUE TO MONITOR AND EVALUATE ALL INCIDENTS BASED ON THE USE OF TLM DEVICES. THE USER FACILITY HAS FILED A MEDWATCH #(B)(4) ON 11/08/2005. TLM DOES NOT EXPECT ADDITIONAL INFO REGARDING THIS INCIDENT. ANY ADDITIONAL DATA OR INFO, IF RECEIVED WILL BE PROVIDED IN A FOLLOWUP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2005, A TLM REPRESENTATIVE WAS CONTACTED BY THE USER FACILITY WITH INFO THAT DURING A CASE, THE SURGEON SET A DS3.0 DEVICE DOWN ONTO A MAGNETIC PAD THAT WAS DRAPED OVER THE PT. SHORTLY AFTER SETTING THE DEVICE DOWN THE SCRUB NURSE HEARD AND SAW ARCING AND SPARKING FROM THE DEVICE TIP. THE SCRUB NURSE GRABBED THE DEVICE AND SUSTAINED A SMALL BURN TO HER FOREARM. THE SALINE FLOW HAD BEEN OFF DURING THIS TIME. AND THE SURGEON WAS NOT SURE IF THE DEVICE HAD DEACTIVATED WHEN HE SET IT DOWN. THERE WAS NO PT INJURY. THE USER FACILITY WAS CONTACTED TWO ADDITIONAL TIMES WITH NO INFO PROVIDED TO TLM. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DS3.0 DISSECTING SEALER DISSECTING SEALER GEI TISSUELINK MEDICAL, INC. 13-101-1 TL033864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other