BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL TROCAR W/UNIVERSAL CONVERTER

    MDR report key: 1237835 · Received November 18, 2008

    Report

    Report Number
    1320894-2008-00153
    Event Type
    Death
    Date Received
    November 18, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 17, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS A FIXED BLADE OBTURATOR WITH SHIELD DEPLOYMENT. NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF THE REPORTED DEFECT. IT WAS REPORTED THAT AFTER THE SURGEON PENETRATED THE ABDOMINAL WALL, DAMAGE WAS DONE TO THE ILIAC ARTERY. A VASCULAR SURGEON WAS CALLED IN TO REPAIR THE DAMAGE. TWO DAYS POST OPERATIVELY, THE PATIENT REPORTEDLY DIED DUE TO BLOOD LOSS. THE MANUFACTURING OF THIS DEVICE WAS MADE TO SPECIFICATION. THESE DEVICES ARE 100% TESTED FOR SHIELD DEPLOYMENT DURING MANUFACTURING. A 24 MONTH REVIEW OF THE CUSTOMER COMPLAINT DATABASE SHOWS NO SIMILAR COMPLAINTS REPORTED. THE DEVICE FOR USE STATES THE CAUTIONS FOR USE OF THE DEVICE. (SEE ATTACHED DFU) WE ARE CONSIDERING THIS COMPLAINT COMPLETE AND CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ALLEGEDLY THE BLADE DIDN'T RETRACT. PATIENT IS DECEASED FOLLOWING BLEEDING TWO DAYS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL TROCAR W/UNIVERSAL CONVERTER SURGICAL TROCAR 5-12MM DIAMETER GCJ CONMED CORPORATION NA 0807181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death