BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2842774 · Received November 21, 2012

    Report

    Report Number
    9612355-2012-00044
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE #: (B)(4). IT WAS REPORTED THAT AT THE END OF AN A-FIB PROCEDURE, WHEN THE GROUNDING PAD WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE PATIENT'S SKIN WAS BURNED FROM THE GROUNDING PAD. THE REPORTER INITIALLY STATED THAT THE PHYSICIAN COMMENTED THAT THE SKIN BURN WAS DUE TO THE POOR CONTACT OF THE GROUNDING PAD WITH THE PATIENT'S SKIN. AFTER FOLLOW UP, THE CUSTOMER CONFIRMED THAT THE EVENT WAS NOT RELATED TO ANY BWI EQUIPMENT AND THE UNIT DID NOT REQUIRE SERVICE. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE REPAIR RECORD INVESTIGATION IS COMPLETED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US: CATALOG # FG540000, SERIAL # (B)(4); COOL FLOW PUMP US: CATALOG # CFP002, SERIAL # (B)(4); EZ STEER THERMOCOOL SF NAV US: CATALOG # BNI35BDH, LOT # 15630706L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF AN A-FIB PROCEDURE, WHEN THE GROUNDING PAD WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE PATIENT'S SKIN WAS BURNED FROM THE GROUNDING PAD. THE SKIN WAS CLEANED WITH BETADINE AND ANTIBIOTICS WERE GIVEN TO THE PATIENT. THE PATIENT WAS STABILIZED AND ADMITTED FOR OBSERVATION. THE CALLER STATED THAT THE PHYSICIAN COMMENTED THAT THE SKIN BURN WAS DUE TO THE POOR CONTACT OF THE GROUNDING PAD WITH THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R