BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR ELECTRODE

    MDR report key: 1173032 · Received September 19, 2008

    Report

    Report Number
    1221934-2008-00449
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY MITEK TO DATE, HAS NOT YET REC'D THE COMPLAINT DEVICE FOR EVAL. HOWEVER THE REPORTED FAILURE MODE OF THE DEVICE IS CONSISTENT WITH FAILURES PRODUCED IN A LAB ENVIRONMENT BY THE APPLICATION OF EXCESSIVE MECHANICAL FORCE. ALTHOUGH IT IS NOT CONCLUSIVE WE COULD NOT IDENTIFY ANY OTHER FACTORS THAT WOULD RESULT IN SUCH AS A FAILURE OTHER THAN THOSE MENTIONED IN THE INSTRUCTIONS FOR USE. ALL THE PIECES WERE RETRIEVED FROM THE PT AND THERE WERE NO PT CONSEQUENCES. WHEN AND IF THE COMPLAINT DEVICE IS REC'D HERE AT DEPUY MITEK IT WILL BE SUBJECTED TO A FAILURE ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE OTHER THAN THE ABOVE HYPOTHESIS, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CALLER IS REPORTING THE TIP OF A VAPR ELECTRODE BROKE OFF, AND FELL INTO PT'S JOINT SPACE. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE AND CASE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR ELECTRODE ELECTROSURGICAL, CUTTING 8 COAGULATION GEI DEPUY MITEK 0803043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK