BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR

    MDR report key: 2190954 · Received August 4, 2011

    Report

    Report Number
    1221934-2011-00288
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 1, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K041135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    MITEK RECEIVED 1 OF THE 2 COMPLAINT DEVICES; CANNOT IDENTIFY WHICH ONE OF THE TWO IT IS. THE DEVICE WAS VISUALLY EVALUATED; BOTH WITH THE NAKED EYE AND UNDER POWER. IT IS NOTED THAT ALTHOUGH THE COMPLAINT NARRATIVE STATED THAT A PORTION OF THE DISTAL TIPS OF BOTH ELECTRODES BROKE AWAY; THIS RETURN'S DISTAL END IS FULLY INTACT. HOWEVER, SOME OF THE BLACK INSULATOR MATERIAL CLOSE TO THE DISTAL TIP IS SCRATCHED OR GOUGED, AND SOME OF IT MISSING. THIS CONDITION HAS HISTORICALLY BEEN ATTRIBUTED TO THE USER ABRADING THE DEVICE AGAINST SOMETHING HARD OR SHARP, LIKE A CANNULA OR SCOPE EDGE. THIS WOULD BE A TECHNIQUE ISSUE. ALTHOUGH THIS IS A HYPOTHESIS AND IS NOT CONCLUSIVE, WE COULD NOT IDENTIFY ANY OTHER FACTORS THAT WOULD RESULT IN SUCH A FAILURE. 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. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, A PORTION OF THE DISTAL TIP OF TWO S90 ELECTRODES BROKE OFF INTO THE PATIENT'S JOINT SPACE. ALL OF THE FRAGMENTS WERE EASILY REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY USING ANOTHER SAME DEVICE WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALSO SEE ASSOCIATED MDR 1221934-2011-00289.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR VAPR S90 ELECTRODE GEI DEPUY MITEK NA M1009057

    Patients

    Seq Age Sex Outcome Treatment
    1