BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM

    MDR report key: 1161585 · Received September 16, 2008

    Report

    Report Number
    3005075853-2008-01744
    Event Type
    Death
    Date Received
    September 16, 2008
    Date of Event
    October 31, 2007
    Report Date
    September 12, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/16/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE PT DIED AS A RESULT OF THIS SURGERY. NO DIRECT PRODUCT COMPLAINT WAS KNOWN OF OR REPORTED AT THE TIME. NO FURTHER INFO IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death