BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1883570 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06105
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. THE PRODUCT INVOLVED IN THIS EVENT WAS IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THERE WAS LOSS OF PNEUMO CONSTANTLY FROM THE VERY BEGINNING OF THE PROCEDURE. DUE TO THIS PROBLEM, THEY HAD TO STOP THE PROCEDURE OFTEN. 'THEY DECIDED NOT TO OPEN.' THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INSULATION TIP CAME OFF THE HARMONIC DEVICE. A NEW HARMONIC DEVICE WAS USED TO CONTINUE THE PROCEDURE. THE RUBBER TIP OF THE TROCARS CAME OFF AND FELL INTO THE PATIENT. THEY WERE RETRIEVED. THE TROCARS WERE SWITCHED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT. NO OTHER DETAILS OF THE EVENT ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4TA96

    Patients

    Seq Age Sex Outcome Treatment
    1