BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR SE ELECTRODE

    MDR report key: 1182699 · Received September 25, 2008

    Report

    Report Number
    1221934-2008-00445
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 16, 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 TO DATE, HAS NOT YET RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. 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. THE SURGEON IS REPORTING THAT THERE WAS NO PATIENT HARM, HOWEVER, THE BROKEN FRAGMENT WAS LEFT IN THE BODY, IT IS POSSIBLE THAT PATIENT INJURY COULD POTENTIALLY OCCUR. BECAUSE OF THIS 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 OTHER THAN THE ABOVE HYPOTHESIS, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR A PORTION OF THE DISTAL END OF A SE ELECTRODE BROKE OFF INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED FROM THE BODY, HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR SE ELECTRODE ELECTROSURGICAL, CUTTING AND COAGULATING GEI DEPUY MITEK 227301 0801102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK