BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*5MM CRVD DISSECTOR

    MDR report key: 3223729 · Received July 12, 2013

    Report

    Report Number
    3005075853-2013-03533
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K984240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT THE INSTRUMENT WAS RETURNED NONFUNCTIONAL. THE INSTRUMENT WAS TESTED AND DID NOT CUT PROPERLY. THE BLADES WERE EXAMINED AND WERE FOUND TO LOOSE POINT OF CONTACT. IT WAS CONCLUDED THAT LOW BIAS FORCE CAUSED THE BLADES TO LOOSE POINT OF CONTACT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, THE JAWS WERE BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323942 ENDOPATH*5MM CRVD DISSECTOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA K4CF81

    Patients

    Seq Age Sex Outcome Treatment
    1