BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR

    MDR report key: 3903016 · Received June 30, 2014

    Report

    Report Number
    3005075853-2014-04498
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    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
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS MEANT BY BLADE MALFUNCTIONED? THE BLADE OF DID NOT CAME OUT WHEN ACTIVATE THE RED BUTTON. WAS BLADE NOT EXPOSED WHILE TRYING TO INSERT TROCAR? YES, THE BLADE IS NOT EXPOSED WHILE TRYING TO INSERT TROCARS. DID SHIELD NOT COVER BLADE ONCE TROCAR INSERTED? SHIELD IS THERE TO COVER. PLEASE PROVIDE MORE DETAILS REGARDING SPECIFIC ISSUE. WAS THERE ANY PATIENT INJURY? IF SO, PLEASE PROVIDE MORE DETAILS REGARDING ISSUE. NO PTS INJURY REPORTED. IF PATIENT INJURY, HOW WAS PATIENT TREATED? NA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE D5LT FOUND THAT IT WAS RECEIVED IN GOOD CONDITION. DURING THE FUNCTIONAL TESTING THE BULLET RETRACTED PERMITTING THE EXPOSURE OF THE BLADE DURING THE ADVANCEMENT THROUGH THE SKIN TEST MEDIA AND RETURNED TO SAFE POSITION UPON PENETRATION; THE BULLET PERFORMED AS INTENDED WITHOUT ANY ANOMALIES NOTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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 TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE BLADE OF DEVICE MALFUNCTIONED; EVEN THE RED ACTIVATION BUTTON HAD BEEN PRESSED. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380717 XCEL DILATING TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 K5LT