BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO 1.0CM LASER FIBER

    MDR report key: 729225 · Received June 22, 2006

    Report

    Report Number
    1527736-2006-02845
    Event Type
    Death
    Date Received
    June 22, 2006
    Date of Event
    November 21, 2003
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GEX
    PMA / PMN Number
    k990851
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3: EVALUATION SUMMARY: INFORMATION REGARDING THE EVENT WAS ORGINALLY REPORTED IN NOVEMBER 2003. AT THIS TIME THE OPERATING SURGEON INDICATED TO US THAT HE DID NOT BELIEVE THE DEVICE WAS RELATED TO THE OUTCOME EXPERIENCED BY THIS PATIENT. HE NOTED NO DIFFICULTIES DURING THE PROCEDURE. WE CONDUCTED AN INVESTIGATION AND CONCLUDED THE DEVICE PERFORMED AS INTENDED AND WAS UNRELATED TO THE PATIENT OUTCOME. A LAWSUIT BY THE PATIENT'S FAMILY HAS NOW BEEN INITIATED AND THE REPORT IS NOW BEING FILED BASED ON THE ALLEGATIONS BEING MADE IN THE LITIGATION. PMA/510(K)# K990851

    Description of Event or Problem · 1

    A BPH PROCEDURE WAS COMPLETED ON THE PATIENT AND 2 DAYS POST OP WAS ADMITTED TO THE HOSPITAL WITH A PERFORATED BOWEL IN THE DISTAL ILEUM. AT THE TIME OF THE REPORTED EVENT, THE SURGEON NOTED NO DIFFICULTIES DURING THE PROCEDURE AND CONCLUDED THE DEVICE PERFORMED AS INTENDED AND UNRELATED TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO 1.0CM LASER FIBER GEX GEX ETHICON ENDO SURGERY, INC. (CINCINNATI) NA T4VR61

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death LASER