BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC ABC PROBE

    MDR report key: 2153541 · Received July 2, 2011

    Report

    Report Number
    2153541
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 2, 2011
    Manufacturer
    CONMED CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HANDPIECE FOR THE ELECTROSURGICAL ARGON DEVICE WAS ON THE SURGICAL FIELD. WHEN THE SURGEONS WENT TO USE THE HANDPIECE IT WOULD NOT ACTIVATE. THE MACHINE SAID THAT THE HANDPIECE NEEDED MAINTENANCE. UPON FURTHER INSPECTION THE SCRUB PERSON NOTICED THAT THE BLACK COATING AROUND THE METAL TIP WAS COMING DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC ABC PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORP. * 1010063
    2 * ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORP 607500120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR