BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH XCEL

    MDR report key: 1666104 · Received April 21, 2010

    Report

    Report Number
    3005075853-2010-01981
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 25, 2010
    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
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL. EVAL SUMMARY: AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. ON 03/25/2010 - THE RISK MGR AT THE ACCOUNT INITIALLY INDICATED THAT THE TROCAR WAS AN ETHICON ENDO-SURGERY DEVICE. SHE ATTEMPTED TO PROVIDE THE PRODUCT CODE BUT WAS UNSUCCESSFUL IN FINDING IT IN THE REPORT. SHE INDICATED THAT SHE HAD PLANNED TO COMPLETE A SAFETY REPORT, BUT THE EVENT WAS MOST LIKELY USER ERROR, SHE STILL PLANS TO SUBMIT A REPORT. SHE WOULD NOT PROVIDE ANY FURTHER DETAIL UNTIL SHE COULD CONFIRM THE PRODUCT INFO. SHE WILL CALL BACK WITH THE INFO; SHE ALSO REQUESTED OUR ADDRESS TO SEND A COPY OF THE REPORT. ON 03/25/2010 - THE RISK MANAGER CALLED BACK, SHE CONFIRMED THAT THE DEVICE WAS A B5LT TROCAR. THE PACKAGING AND THE DEVICE WAS DISCARDED. THE VERESS NEEDLE UTILIZED WAS MANUFACTURED BY TYCO. ON 03/26/2010 - THE RISK MGR CALLED INDICATING THE PRODUCT WAS A B5XT. IN ADDITION, THE SALES REPRESENTATIVE CALLED STATING THIS ACCOUNT IS NOT A RECENT CONVERSION. ON 03/25/2010 - REVIEWED INCIDENT WITH THE EES MEDICAL CONSULTANT AND LEFT MESSAGE WITH THE RISK MGR ON 03/29/2010: ON 04/13/2010 - EES RISK MGR LEFT MESSAGE WITH THE RISK MANAGER AT THE ACCOUNT FOR ANY ADD'L INFO.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE MEDICAL EXAMINER THAT A LAPAROSCOPIC PARTIAL NEPHRECTOMY WAS BEING PERFORMED. THE PT WAS IN A DECUBITUS POSITION. THE SURGEON WAS ATTEMPTING TO OBTAIN PNEUMOPERITONEUM. THE SURGEON DISSECTED WITH HIS FINGER, A VERESS NEEDLE WAS INSERTED, IT IS UNK IF PNEUMO WAS THEN ACHIEVED. A "5 FR OPTIVIEW" WITH A 0 DEGREE LENS WAS THEN ENTERED. AT THAT TIME THE ANESTHESIOLOGIST OBSERVED A DROP IN THE BLOOD PRESSURE. THE PT ARRESTED. THE ME INDICATED HE OBSERVED THE DISSECTION IN THE RETROPERITONEUM. HE OBSERVED 2 DEFECTS IN THE AORTA, BOTH APPEARED IRREGULAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death