BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 ELECTRODE

    MDR report key: 2141679 · Received June 27, 2011

    Report

    Report Number
    1221934-2011-00252
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 27, 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

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED VISUALLY. THE ELECTRODE WAS VIEWED BOTH WITH THE NAKED EYE AND UNDER POWER; IT IS NOTED THAT THE DISTAL TIP HAS SOME DAMAGE THAT CAN ONLY BE ATTRIBUTED TO ABUSE. THE ACTIVE PORTION OF THE DISTAL END AND THE SURROUNDING MATERIAL AT THE 1-3 O'CLOCK AREA IS BROKEN AWAY; THE BREAK APPEARS TO BE VIOLENT AS OPPOSED TO A PASSIVE OR HEAT BREAK; THERE ARE SEVER SCRAPE MARKS ALONG THE AREA AS IF THE DEVICE WAS RIGOROUSLY ABRADED AGAINST SOMETHING HARD. THE FAILURE OF THIS DEVICE IS ATTRIBUTABLE TO TECHNIQUE; A USER 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

    THE FACILITY CALLED AND REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF AN S90 ELECTRODE CAME OFF AND INTO THE PATIENT'S JOINT SPACE. IT IS NOT KNOWN IF THE FRAGMENT REMAINS IN THE BODY OR NOT, HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR S90 ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATING GEI DEPUY MITEK NA M1101072

    Patients

    Seq Age Sex Outcome Treatment
    1