BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1771817 · Received July 28, 2010

    Report

    Report Number
    3005075853-2010-04245
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 2010
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE TROCARS WERE LEAKING FROM THE SEAL CAP. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SAME TROCARS. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO DEPLOY, DIFFICULT TO REMOVE. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A TECH TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT DIFFICULTY WAS ENCOUNTERED HALFWAY THROUGH DEPLOYMENT. ADDITIONAL PRESSURE WAS APPLIED ENABLING COMPLETION OF THE THUMB ADVANCER DEPLOYMENT. AFTER DEPLOYING THE CLIP, RESISTANCE WAS ENCOUNTERED DURING DEVICE REMOVAL. A DILATOR WAS INSERTED INTO THE ACCESS PORTS WHICH RELEASED THE DEVICE FROM THE PT ANATOMY. WHEN THE DEVICE WAS REMOVED, HEMOSTASIS WAS ACHIEVED, AND THE CLIP WAS DEPLOYED IN THE INTENDED LOCATION IN THE VESSEL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1