BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3074496 · Received April 24, 2013

    Report

    Report Number
    9612355-2013-00019
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). NAVISTAR DS CATHETER, MODEL #: D-1201-19-S, LOT #: UNKNOWN_D-1201-19-S. WEBSTER CS WITH AUTO ID CATHETER, MODEL #: D-1353-04-S, LOT #: UNKNOWN_D-1353-04-S. NON BWI - PATIENT RETURN ELECTRODE 9 INCH VALLEY LAB (SERIAL # (B)(4)).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE #:(B)(4). IT WAS REPORTED THAT AFTER PERFORMING AN ATRIAL FLUTTER (AFL) PROCEDURE, A BURN WAS NOTED ON THE PATIENT'S LEFT SIDE AS THE GROUNDING PAD WAS REMOVED. IT WAS A SECOND DEGREE BURN. TOPICAL OINTMENT WAS ADMINISTERED TO THE PATIENT AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE STOCKERT WAS SENT IN FOR EVALUATION IN ORDER TO RECREATE THE REPORTED CONDITION, HOWEVER, THE UNIT WAS FOUND FUNCTIONAL AND READY FOR USE DURING THE SERVICING. FUNCTIONAL TEST AND PREVENTIVE MAINTENANCE WERE PERFORMED TO THE UNIT. ALSO AS A PART OF A SUPPLIER CORRECTIVE ACTION OPENED TO ADDRESS NIS BOARD ISSUES, ALL UNITS RECEIVED FOR SERVICING REQUIRE THE UPGRADE OF THE NIS BOARD. THIS UPGRADE IS DONE TO ENHANCE THE FUNCTIONALITY OF THE BOARD AND IT IS BEING PERFORMED EVEN IF THE UNIT DOES NOT PRESENT ANY MALFUNCTION AS SEEN ON THIS PARTICULAR EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERFORMING AN ATRIAL FLUTTER (AFL) PROCEDURE, A BURN WAS NOTED ON THE PATIENT'S LEFT SIDE AS THE GROUNDING PAD WAS REMOVED. IT WAS A SECOND DEGREE BURN. TOPICAL OINTMENT WAS ADMINISTERED TO THE PATIENT AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. FOLLOWING AN ATRIAL FLUTTER ABLATION, THE PATIENT WAS FOUND TO HAVE A BURN ON HER LEFT FLANK. THE GROUNDING PAD WAS FALLING OFF THE PATIENT WHEN REMOVED. IT WAS DETERMINED THAT THE GROUNDING PAD WAS NOT PLACED ON THE PATIENT PROPERLY AND CAUSED A SKIN BURN. THE BURN WAS NOT MEDICALLY TREATED DIFFERENTLY THAN ROUTINE CLINICAL PRACTICE. THE PATIENT WAS GOING TO REQUIRE FURTHER TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY WHAT TYPE OF FURTHER TREATMENT THE PATIENT REQUIRED, BUT NO CLARIFICATION HAS BEEN RECEIVED. THE EVENT WAS NOT LIFE THREATENING. THE EVENT DID NOT RESULT IN THE PERMANENT NON-TRIVIAL IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE INCIDENT DID NOT NECESSITATE SURGICAL INTERVENTION TO PRECLUDE PERMANENT, NON-TRIVIAL DAMAGE TO A BODY STRUCTURE. THE EVENT DID NOT REQUIRE HOSPITALIZATION OR AN EXTENDED HOSPITAL STAY. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PROGNOSIS FOR THE PATIENT WAS EXCELLENT. THE CAUSALITY OF THE ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. THE PATIENT RETURN ELECTRODE USED WAS THE 9 INCH VALLEY LAB (SERIAL # (B)(4)). THE PATIENTS UPDATED HEALTH STATUS WAS UNKNOWN. THE RF GENERATOR WAS SET TO 70 WATTS. THE TOTAL ABLATION PROCEDURE DURATION WAS 23 MINUTES. MIN: :03 SEC AND MAX: 2:11 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177351 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R