BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 8116809 · Received November 29, 2018

    Report

    Report Number
    1717344-2018-01560
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 1, 2018
    Report Date
    February 25, 2019
    Manufacturer
    NEW DEANTRONICS LTD
    Product Code
    GEI
    UDI-DI
    10884521196636
    PMA / PMN Number
    K982743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE PRODUCT WAS NOT INCLUDED IN THE PICTURES PROVIDED. THE PICTURE SHOWED BURNS ON A PATIENT. THE REPORTED CONDITION WAS NOT CONFIRMED BECAUSE THE ACTUAL DEVICE WAS NOT RECEIVED. WITHOUT THE PRODUCT, A DETAILED INVESTIGATION COULD NOT BE PERFORMED. THE FILE WILL BE CLOSED AS UNCONFIRMED AT THIS TIME. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE PRODUCT IS RETURNED, WE WILL RE-OPEN THIS INVESTIGATION. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT SUFFERED FROM 3RD DEGREE BURN ON THE FACE AROUND THE NOSE. UPON TESTING OF THE DEVICES, IT WAS SEEN THAT THE GENERATOR HAD CURRENT LEAKAGE UNDER THE FOLLOWING SETTINGS: "ATIVE", FUNCTION PURE CUT - 329MA "ATIVE", FUNCTION COAG - 196MA DISPERSIVE, FUNCTION PURE CUT - 250MA DISPERSIVE, FUNCTION COAG - 63MA. ALSO THE PENCIL WAS ARCING AND SPARKING.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT SUFFERED FROM 3RD DEGREE BURN ON THE FACE AROUND THE NOSE. UPON TESTING OF THE DEVICES, IT WAS SEEN THAT THE GENERATOR HAD CURRENT LEAKAGE UNDER THE FOLLOWING SETTINGS : ATIVE, FUNCTION PURE CUT - 329MA ATIVE, FUNCTION COAG - 196MA DISPERSIVE, FUNCTION PURE CUT - 250MA DISPERSIVE, FUNCTION COAG - 63MA. ALSO THE PENCIL WAS ARCING AND SPARKING AND THERE WAS A FIRE PRESENT BUT EXTINGUISHED BY CLOTH. THE ANALYSIS OF THE PICTURE PROVIDED SHOWS THAT THE NASAL CANNULA WAS BURNT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT SUFFERED FROM 3RD DEGREE BURN ON THE FACE AROUND THE NOSE. UPON TESTING OF THE DEVICES, IT WAS SEEN THAT THE GENERATOR HAD CURRENT LEAKAGE UNDER THE FOLLOWING SETTINGS: ATIVE, FUNCTION PURE CUT - 329MA ATIVE, FUNCTION COAG - 196MA DISPERSIVE, FUNCTION PURE CUT - 250MA DISPERSIVE, FUNCTION COAG - 63MA. ALSO THE PENCIL WAS ARCING AND SPARKING AND THERE WAS A FIRE PRESENT BUT EXTINGUISHED BY CLOTH. THE ANALYSIS OF THE PICTURE PROVIDED SHOWS THAT THE NASAL CANNULA WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955201 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NEW DEANTRONICS LTD VL2610 1702031X 10884521196636

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR