BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1881661 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06054
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 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
    KY, US
    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

    THE COMPANY WAS INFORMED THAT THE PT UNDERWENT A DEBRIDEMENT DUE TO SKIN BREAKDOWN AT THE IMPLANT SITE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADD'L INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFO IS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE TROCARS WERE LEAKING FROM THE SEAL. ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1