BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED APPLIER

    MDR report key: 2042093 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01371
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION RECEIVED REGARDING THE EVENT: PROCEDURE? ONCOLOGICAL THROAT &NECK RESECTION. HOW WAS THE BLEEDING CONTROLLED? ANOTHER MCM20 WAS USED. ANY BLOOD PRODUCTS GIVEN TO THE PATIENT? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE IMPRESSION WAS THAT THE CLIPS HAD SOME SHARP EDGES WHICH CUT ON THE BLOOD VESSELS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1