BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK VAPR ANGLED SE ELECTRODE

    MDR report key: 3052450 · Received April 11, 2013

    Report

    Report Number
    1221934-2013-00098
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K974022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTY-ONE DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO US, AND NOTHING HAS BEEN RECEIVED, WHICH PRECLUDES CONDUCTING AN EVALUATION. HOWEVER, A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED 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.

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED ON 3-9-2015 AND EVALUATED. VISUAL OBSERVATION UNDER MAGNIFICATION REVEALED THE CERAMIC TIP INSULATOR PIECE IS BROKEN. THE BROKEN PIECE WAS RECEIVED BY MITEK. THERE WAS SALINE RESIDUE PRESENT ON THE ELECTRODE, INDICATING THE DEVICE HAD BEEN USED. THE DAMAGE TO THE TIP INSULATOR IS LIKELY TO BE CAUSED BY THE INTRODUCTION OF ANOTHER METAL INSTRUMENT DURING THE PROCEDURE. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTRO SURGERY 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 AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ THE ELECTRODE WAS NOT TESTED TO PREVENT FURTHER DAMAGE. THE REPORTED COMPLAINT CAN BE CONFIRMED. THIS TYPE OF FAILURE CAN BE ATTRIBUTED TO USER TECHNIQUE ISSUE. 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. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE OVERALL COMPLAINT RATE FOR THIS FAILURE MODE, AT THIS POINT, 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

    OUR AFFILIATE IS REPORTING TO US THAT THE PATIENT UNDERWENT A SUCCESSFUL ARTHROSCOPIC KNEE REPAIR ON (B)(6) 2013. DURING A FOLLOW-UP X-RAY EXAMINE THE NEXT DAY, (B)(6) 2013, THE IMAGING REVEALED A FOREIGN OBJECT AROUND THE PATELLA. UNDER LOCAL ANESTHESIA ON THIS SAME DAY, THE SURGEON REMOVED THE FRAGMENT WHICH WAS DISCERNED TO BE FROM THE DISTAL TIP OF THE ELECTRODE USED THE PREVIOUS DAY, A MITEK VAPR ANGLED SIDE EFFECT ELECTRODE. THIS PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156635 MITEK VAPR ANGLED SE ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA M1205047

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention