BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS* SEAL CAP

    MDR report key: 1925468 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07091
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IRIS SEAL. THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS RECEIVED DISASSEMBLED AND WITH THE IRIS TORN. THE TEAR INITIATED BELOW TO THE UPPER INNER RING AND PROPAGATED 360 DEGREES TO THE UPPER RING. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FINDING. THE ANALYSIS RESULTS OF DEVICE (B) FOUND THAT IT WAS RECEIVED WITH THE IRIS TORN. THE TEAR INITIATED BELOW TO THE UPPER INNER RING AND SPIRALED TOWARD THE LOWER RING. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FINDING. 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 A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE SEAL RIPPED ALL THE WAY AROUND THE SEAL AS THE SURGEON WAS PUTTING A HAND THROUGH. THE SECOND RIPPED WHILE THE SURGEON WAS REMOVING A HAND FROM THE DEVICE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** DEXTRUS* SEAL CAP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1