BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DEXTRUS HAND ACCESS

    MDR report key: 3897171 · Received June 26, 2014

    Report

    Report Number
    3005075853-2014-04390
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE HAP02 DEVICE WAS RECEIVED WITH THE IRIS SEAL TORN. THE INITIATION SITE APPEARED TO BE ADJACENT TO THE O-RING AND THEN IT PROPAGATED TOWARD THE LOWER SEAL RING. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE, OPENED THE PRODUCT AND THE RUBBER HAS A HOLE IN IT. PRODUCT WAS NOT PLACED ON STERILE FIELD. THE TECH OPENED ANOTHER OF THE SAME ITEM AND NO OTHER PROBLEMS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373760 ENDOPATH DEXTRUS HAND ACCESS LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4DK36

    Patients

    Seq Age Sex Outcome Treatment
    1