BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROLASE DISPOSABLE MICRONEEDDLE ELECTRODE

    MDR report key: 3828281 · Received May 22, 2014

    Report

    Report Number
    1320894-2014-00056
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    UNIMED SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K944265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED BY CONMED AND MANUFACTURED BY UNIMED SURGICAL PRODUCTS, INC. THE 510K IS HELD BY UNIMED. REPORTING FOR THIS ADVERSE EVENT IS THE RESPONSIBILITY OF UNIMED SURGICAL PRODUCTS, INC.. I ATTEMPTED TO CONTACT UNIMED REGARDING THE REPORTABILITY OF THIS EVENT BY EMAIL ON (B)(4) 2014. THE EMAIL WAS RETURNED TO ME AS UNDELIVERABLE MAIL A MONTH LATER ON (B)(4) 2014. AT THAT TIME I SENT TO UNIMED THE INFORMATION REGARDING REPORTABILITY OF THIS EVENT BY USPS CERTIFIED MAIL. THIS CERTIFIED MAIL PACKAGE WAS RETURNED TO ME AS UNDELIVERABLE. I WAS ADVISED BY THE CONMED REGULATORY DEPARTMENT TO PLACE A MEDWATCH TO THE FDA AS THE DISTRIBUTOR OF THIS DEVICE JUST TO MAKE THE FDA AWARE OF THIS EVENT. THE DEVICE HAS STILL NOT BEEN RETURNED TO CONMED CORPORATION FROM THE END-USER FACILITY. NO CONCLUSIONS CAN BE MADE REGARDING THIS REPORTED EVENT; HOWEVER, FROM THE DESCRIPTION OF THE EVENT FROM THE END-USER FACILITY THE ROOT CAUSE CAN BE GUESSED AS THE INSULATION OF THE ACTIVE ELECTRODE WAS COMPROMISED BY THE END-USER WHEN THEY "MANIPULATED (THE ELECTRODE) WITH A FORCEP TO INTRODUCE THER MICRONEEDLE INSIDE RTHE GOLDVAC PENCIL." THIS MAY HAVE CAUSED A BREAK IN THE INSULATION AND A POINT WHERE THE ELECTRODE ARCED TO THE BURN SITE. CONMED HAS IS NO LONGER DISTRIBUTING ANY UNIMED SURGICAL PRODUCT DEVICES. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. NEVER RETURNED TO CONMED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING SURGERY DOCTOR SAW A SPARK FROM THE MICRONEEDLE INSULATION THAT SPARKED BURN THE PATIENT UPPER LIP SMALL REPAIR WAS DONE IMMEDIATELY. PATIENT STATUS GOOD DID NOT NEED HOSPITALIZATION. THE INSULATION FAILURE IS DUE TOO MICRONEEDLE MANIPULATION WITH A FORCEP TO INTRODUCE THE MICRONEEDLE INSIDE THE GOLDVAC PENCIL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305780 ELECTROLASE DISPOSABLE MICRONEEDDLE ELECTRODE MICRONEEDLE GEI UNIMED SURGICAL PRODUCTS, INC. 062211-09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention