BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR COOLPULSE 90 ELECTRODE

    MDR report key: 4191074 · Received October 21, 2014

    Report

    Report Number
    1221934-2014-00450
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RECEIVED. HOWEVER, THE PICTURE PROVIDED CONFIRMS THAT THE METAL TIP IS BROKEN AND SEPARATED FROM THE SHAFT. WITHOUT PHYSICALLY EXAMINING THE DEVICE, A ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. THIS TIP BREAK FAILURE ON CP90 ELECTRODES ARE BEING INVESTIGATED UNDER A SUPPLIER CAPA. FOUR POSSIBLE ROOT CAUSES HAVE BEEN IDENTIFIED RELATED TO DESIGN, MANUFACTURING AND USE. CORRECTIVE ACTIONS WHICH INVOLVE DESIGN AND PROCESS IMPROVEMENT ACTIVITIES WERE IDENTIFIED FOR EACH OF THE ROOT CAUSE AND ARE BEING CURRENTLY INVESTIGATED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW INTO THE COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. (B)(4). 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

    LOOSE METALPART FROM THE TIP OF THE VAPR ELECTRODE. **ADDITIONAL INFORMATION FROM THE AFFILIATE WHAT TYPE OF PROCEDURE WAS THIS? DEKOMPRESSION SHOULDER. WHAT WAS THE DATE OF THE PROCEDURE? (B)(6) 2014. DID THE TIP FALL INTO THE PATIENT? YES. HOW WAS IT REMOVED? WITH A GRASPER. HOW WAS THE PROCEDURE COMPLETED? HOW LONG DID THIS FAILURE EXTEND THE PROCEDURE TIME, MORE THAN 30 MINUTES? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670223 MITEK VAPR COOLPULSE 90 ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1404069

    Patients

    Seq Age Sex Outcome Treatment
    1