BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSH-BUTTON ELECTROSURGICAL PENCIL

    MDR report key: 7154138 · Received December 29, 2017

    Report

    Report Number
    9613793-2017-00008
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    November 26, 2017
    Report Date
    January 12, 2017
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    GEI
    PMA / PMN Number
    K940909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A ROOT CAUSE IS UNABLE TO BE DETERMINED. NO ISSUES WERE FOUND IN THE DOCUMENTATION ON HAND, AND A DEFECTIVE SAMPLE WAS NOT RETURNED FOR EVALUATION. CORRECTIVE ACTION: NO CORRECTIVE ACTIONS WERE TAKEN DUE TO THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING AN ELECTROSURGICAL PENCIL FIRED RANDOMLY, CAUSING A BURN TO A PATIENT. THE DEFECTIVE SAMPLE WAS THROWN AWAY AND NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER (45316121) WAS REVIEWED AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING PROCESS. THE SUB-ASSEMBLY WORK ORDERS ASSIGNED TO THE FINISHED PRODUCT ALSO WERE REVIEWED. NO REJECTS WERE REPORTED IN THE CONTINUITY TEST RESULTS. ADDITIONALLY, NO ISSUES WERE DETECTED DURING WORK ORDER IN PROCESS. THE LAST TWO CLOSED WORK ORDERS FOR PART NUMBER 88-000002CR (THE PENCIL SUB-ASSEMBLY) WERE REVIEWED AND NO REJECTS WERE REPORTED DURING THE MANUFACTURING PROCESS. A REVIEW OF PAST COMPLAINTS FOR TWO YEARS WAS CONDUCTED AND NO SIMILAR ISSUES HAVE BEEN REPORTED. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN DUE TO THE ROOT CAUSE DETERMINATION. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING AN ELECTROSURGICAL PENCIL FIRED RANDOMLY, CAUSING A BURN TO A PATIENT. THE DEFECTIVE SAMPLE WAS THROWN AWAY AND NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS ONGOING AS OF THE DATE OF THIS REPORT. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE CAUTERY PENCIL FIRED RANDOMLY AND A PATIENT SUFFERED A BURN IN THE MIDDLE OF THEIR CHEST.

    Description of Event or Problem · 1

    THE CAUTERY PENCIL FIRED RANDOMLY AND A PATIENT SUFFERED A BURN IN THE MIDDLE OF THEIR CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935040 PUSH-BUTTON ELECTROSURGICAL PENCIL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. 88-000002 45316121

    Patients

    Seq Age Sex Outcome Treatment
    1