BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR VUE GENERATOR

    MDR report key: 2760518 · Received September 26, 2012

    Report

    Report Number
    1221934-2012-00235
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. AWAITING RETURN OF COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RECEIVED AND WAS EVALUATED. VISUALLY, THE DEVICE HAD SOME MINOR COSMETIC DEFECTS TO THE CHASSIS, NOTHING GROSS OR INFLUENTIAL. FUNCTIONALLY, THE UNIT WAS SUBJECTED TO A THOROUGH BATTERY OF TEST. THE UNIT PASSED ALL TEST, FUNCTIONED WELL WITHIN ITS DESIGN AND MANUFACTURED PARAMETERS. THE CUSTOMERS COMPLAINT COULD NOT BE DUPLICATED; WE COULD FIND NO FAULT WITH THE DEVICE. WE CANNOT DISCERN ANY ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION THAT IS PERTINENT AND GERMANE 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 REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, WHILE HOLDING AN S90 VAPR ELECTRODE AND ACTIVATING THE ABLATION MODE, THE SURGEON RECEIVED A SMALL SHOCK (SENSED CURRENT); THE VIDEO MONITOR ALSO DISPLAYED SOME INTERFERENCE AT THE SAME TIME. THEY OPENED ANOTHER SAME DEVICE AND USED IT WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT ALSO SEE ASSOCIATED MDR 1221934-2012-00230.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR VUE GENERATOR ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1