BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR SE ELECTRODE

    MDR report key: 1063049 · Received June 19, 2008

    Report

    Report Number
    1221934-2008-00312
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 12, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY MITEK HAS NOT RECEIVED THE COMPLAINT DEVICE, IF AND WHEN THE DEVICE RECEIVED, IT WILL BE EVALUATED. HOWEVER, THE REPORTED FAILURE MODE OF THE DEVICE IS CONSISTENT WITH FAILURES PRODUCED IN A LABORATORY 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 A FAILURE OTHER THAN THOSE MENTIONED IN THE INSTRUCTIONS FOR USE. ALSO, THIS IS A SINGLE USE DEVICE AND IT IS NOT ESTABLISHED IF THE DEVICE IN FACT SAW ONLY ONE USAGE, IN OTHER WORDS, THERE IS THE QUESTION OF THE POSSIBILITY THAT THE COMPLAINT DEVICE HAS BEEN REPROCESSED, WHICH WOULD ADD ANOTHER DIMENSION TO THE FAILURE ISSUE. HOWEVER, IF THIS WAS TO RECUR AND THE BROKEN FRAGMENT NOT RETRIEVED FROM THE PT, IT IS POSSIBLE THAT PT INJURY COULD POTENTIALLY OCCUR. BECAUSE OF THE POTENTIALITY AN MDR IS BEING FILED TO DOCUMENT THIS EVENT. WHEN AND IF THE COMPLAINT DEVICE IS RECEIVED HERE AT DEPUY MITEK, IT WILL BE SUBJECTED TO A FAILURE ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRODE CRACKED DURING SURGERY. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES WITHOUT PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR SE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATING GEI DEPUY MITEK 227301 M0712024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK