BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*

    MDR report key: 1936094 · Received December 22, 2010

    Report

    Report Number
    3005075853-2010-07346
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 6, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE DUCKBILL TORN AND OUT OF POSITION. ONE POTENTIAL CAUSE FOR THE DAMAGE FOUND MAY BE THE SNAGGING OF AN INSTRUMENT DURING INSERTION. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE FOUND DUCKBILL ISSUES. 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 LAPAROSCOPIC ROUX-EN-Y PROCEDURE THE DUCKBILL SEAL FELL INTO THE PATIENT. THE SEAL WAS RETRIEVED THROUGH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    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 G4U63P

    Patients

    Seq Age Sex Outcome Treatment
    1