BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 2991587 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01103
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. 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 DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE TROCAR WAS LEAKING AIR FROM THE ABDOMEN. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95645 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1