BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 SUCTION ELECTRODE W/INTEGRATED HANDPIECE

    MDR report key: 3935376 · Received July 15, 2014

    Report

    Report Number
    1221934-2014-00300
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS A PORTION OF THE ACTIVE TIP IS BROKEN AND NOT RETURNED. THE X-RAY CONFIRMED THAT THE BROKEN TIP WAS NOT LEFT INSIDE THE PATIENT. THEREFORE, IT CAN BE ASSUMED THAT THE BROKEN PIECE HAS BEEN FLUSHED OUT. THERE IS SIGNIFICANT AMOUNT OF TISSUE DEBRIS AROUND THE ACTIVE TIP AND SALINE DEBRIS INSIDE THE SUCTION TUBE INDICATING IT WAS USED FOR A PROLONGED PERIOD OF TIME. THIS TYPE OF DISINTEGRATION OF THE TIP IS LIKELY TO BE CAUSED BY THE INTRODUCTION OF ANOTHER INSTRUMENT SUCH AS AN ARTHROSCOPE DURING THE PROCEDURE. THE IFU STATES ¿OBSERVE EXTREME CAUTION WHEN USING ELECTROSURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. THE MAJORITY OF ARTHROSCOPES AND ARTHROSCOPIC INSTRUMENTS ARE METAL. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE TIP IS IN CONTACT WITH ANOTHER METAL OBJECT; LOCALIZED HEATING OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ TOUCHING THE TIP OF THE SCOPE DURING USE IS CONTRARY TO THE PRECAUTIONS STATED IN THE IFU AND WOULD CAUSE THE DAMAGE SEEN TO THE CERAMIC AT THE DISTAL TIP. THIS FAILURE COULD BE ATTRIBUTED TO MISUSE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. THIS FAILURE WAS REVIEWED AGAINST THE RISK ANALYSIS AND IS CONSISTENT WITH THE EXPECTED OUTCOME. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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 DEVICE WAS INTACT AFTER OPENING THE PACKAGE. DURING USE, THE SURGEON NOTED THAT PART OF THE TIP WAS BROKEN, THE SMALL BROKEN PIECE WAS MISSING. THE PATIENT WAS TREATED WITH X-RAY BUT COULD NOT FIND ANY PIECE IN THE BODY. TILL NOW, NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413883 MITEK VAPR S90 SUCTION ELECTRODE W/INTEGRATED HANDPIECE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA M1301108

    Patients

    Seq Age Sex Outcome Treatment
    1